Lava Lava Network Open Interface CAD Design: 3M ESPE AG 3M ESPE

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1 Lava Lava Network Open Interface Instructions for Use CAD Design: Lava Frame Lava DVS Lava Wax 3M ESPE AG Dental Products D Seefeld - Germany 3M ESPE Dental Products St. Paul, MN U.S.A. 3M, ESPE, Filtek, Garant, Penta, Protemp, RelyX and Sof-Lex are trademarks of 3M or 3M ESPE AG. 3M All rights reserved /01

2 Lava Frame Zirconia Crown/Bridge Mill Blanks Product Description Lava Frame Zirconia mill blanks are used for the fabrication of frameworks for all-ceramic restorations. All of the Lava products are manufactured by or for 3M ESPE. Lava Frame blocks conform with ISO 6872:2008 Type II, Class 6. TEC ( C): 10,5 +/-0, K -1. These Instructions for Use concentrate on the indications, the framework design, finishing, veneering and cementation and are therefore limited to a part of the whole system. For details on all mentioned products, please refer to the respective Instructions for Use. These Instructions for Use should not be discarded for the duration of product use. Indications Fabrication of all-ceramic frameworks for the anterior and posterior teeth, taking into consideration the prescribed coping wall thicknesses and connector cross-sections, see Framework Design : Single Crowns Bridges up to 48mm in length with a maximum of two pontics next to one another in the posterior area and a maximum of four pontics next to one another in the anterior area. A maximum of four dies is approved for 5-unit and 6-unit bridges. Crowns on implants and 3-unit bridges on two implants. Lava restorations on implants have not been released for use on patients with bruxism. Lava restorations on implants should have a passive (tension-free) fit. Splinted crowns (maximum 4splinted crowns) Cantilever bridges with a maximum of 1 pendant at the position of a premolaror incisor (cantilever bridges are not approved for use in patients with bruxism) 3-unit inlay/onlay and 2-unit or 3-unit Maryland bridges (excluded for patients with bruxism) Primary crowns Perfectly fitting restorations can be manufactured only in compliance with the preparation guidelines, see Lava Design Software Operating Instructions. The guidelines set forth by the relevant national health care supervisory agencies must also be observed for the respective indications. Tests have proven that Lava Frame shows sufficient strength for inlay/onlay and Maryland bridges. However, this type of indication overall can have a higher failure risk due to decementation and secondary caries regardless of the manufacturer. Please refer to national and regional dental associations for more information. Precautionary Measures 3MESPE MSDSs can be obtained at or from your local subsidiary. Framework Design The coping wall thicknesses and connector cross-sections are decisive for the strength of the later restoration. For Lava Frame, the following design specifications must be observed: Coping wall thicknesses Coping wall thickness in general Anterior copings Primary copings Must not be less than 0.5 mm 0.3 mm, but not in cases of bruxism 0.3 mm, but not in cases of bruxism 1

3 Abutment tooth copings to the cantilever bridge unit for posterior teeth Abutment tooth copings to the cantilever bridge unit for anterior teeth Abutment tooth copings to the anterior tooth bridges with 3 or 4 bridge units 0.7 mm 0.6 mm 0.7 mm All of the restorations created using wax modeling must also meet the wall thicknesses shown above. The system automatically checks this as a safety measure. Connector cross-sections Anterior tooth bridge unit - bridge unit 7 mm 2 (up to 2 bridge units) 10 mm 2 (more than 2 bridge units) Anterior tooth die bridge unit 7 mm 2 (up to 2 bridge units) 10 mm 2 (more than 2 bridge units) Anterior tooth die die 7 mm 2 Anterior tooth die - cantilever bridge unit 8 mm 2 Anterior tooth Maryland wing bridge unit 7 mm 2 Posterior tooth bridge unit - bridge unit 12 mm 2 Posterior tooth die - bridge unit 9 mm 2 Posterior tooth die - die 9 mm 2 Posterior tooth die - cantilever bridge unit 12 mm 2 Posterior tooth inlay - bridge unit 9 mm 2 Maryland bridges 2-unit and 3-unit Maryland bridges Bridge unit at the position of an incisor. Bridge unit with one wing on one or both sides. 3-unit inlay bridges The bridge unit is mesially and distally anchored to the natural tooth by an inlay. Caution: Failure to observe the prescribed minimum wall thickness or connector cross-section may cause fracture of the later restoration. In extreme cases, the patient may swallow or even breathe in parts, resulting in risks to his/her health. Surgical intervention may be required under certain circumstances. In general, the risk of fracture and/or decementation is greater for cantilever bridges, inlay bridges and Maryland bridges. Consequently, these indications should be used only on vital abutment teeth without increased mobility and in patients with good oral hygiene. They are not indicated for patients with parafunctions (e.g., bruxist patients). When inlay and Maryland bridges are used, do not set a strong occlusal contact point on the bridge framework. Cantilever bridges should be 2

4 removed from the occlusion. The guidelines of the relevant national professional associations must also be observed for such indications. Many textbooks recommend as a minimum the same number of abutments and bridge units for longspan bridges to secure the stability of the restoration. Users are themselves responsible for the use of Lava Frame only for the approved indications, for observing the prescribed minimum wall thicknesses and connector crosssections, and for the correct positioning of the holding pins. Finishing the Sintered Framework 8 Finish sintered frameworks using a turbine at 30,000 to 120,000 rpm or with a fast-running handpiece at up to 30,000 rpm. The use of any water cooling which is available can always be recommended, but is not necessary for selective adjustments. 8 Use only fine-grain diamonds with grain sizes between fine 30 µm (red) and extra-fine 15 µm (yellow). Whether the diamonds are bonded galvanically or ceramically is of importance only for the endurance of the diamond cutter. 8 To avoid overheating the framework, apply only light pressure and smooth a particular place for only a short time. 8 If there is cervical smoothing, whether intentionally or accidentally, on a connector, the position must be polished again. Diamond-equipped rubber polishers, discs or cones, are suitable for this, coarse = blue, medium = pink, fine = gray (high polish). 8 Check the wall thickness of the framework before veneering. The minimum values for wall thicknesses and connectors must be maintained after finishing, see Framework Design. Restorations which are scanned using a wax-up and designed without the aid of a computer (CAD) must also meet the requirements for minimum wall thicknesses. Veneering Veneering of Lava Frame restorations is mandatory. Use Lava Ceram veneer ceramic or Lava DVS Digital Veneering System for veneering; they have been especially developed for this Zirconia framework material. Please comply with the Instructions for Use of Lava Ceram or Lava DVS when processing. Inlay bridges may be veneered either with Lava Ceram (see the Instructions for Use for Lava Ceram) or with a molded ceramic approved expressly for Zirconia. The Noritake Cerabien Press or Ivoclar e.max ZirPress molded ceramic is recommended for Lava Frame frameworks. 3M ESPE cannot conduct regular quality inspections of this molded ceramic. This is the responsibility of the molded ceramic manufacturer. When Lava Ceram veneer ceramic for inlay bridges is used, the veneer must be applied to a fireproof die (e.g., Begoform embedding mass, Noritake-Norivest Zirconia). Never remove Lava Ceram or Lava DVS veneers with hydrofluoric acid, since this substance damages the Lava Frame restoration. Temporary Cementation 8 Clean the Lava Frame restoration thoroughly. 8 If you are planning to use a composite cement to cement the restoration permanently, a eugenolfree luting cement (e.g., RelyX Temp NE, manufactured by 3M ESPE) must be used for the temporary cementation. Residuals of products containing eugenol inhibit the setting of composite cement during the permanent cementation process! 8 If you are planning to use a conventional cement to seat the restoration permanently, you may use eugenol-free temporary luting cements or such containing eugenol (e.g., RelyX Temp NE or RelyX Temp E, manufactured by 3M ESPE). 3

5 Permanent Cementation 8 Please see the appropriate Instructions for Use for detailed information about the products mentioned below. Conventional Cementation 8 Thoroughly clean the restoration and blast the interior surfaces of the crowns with aluminum oxide 50 µm. 8 Use a conventional glass ionomer cement, e.g., Ketac Cem, manufactured by 3M ESPE, for the cementation.the use of phosphate cements will not lead to the desired esthetic results. Adhesive Cementation Lava Frame restorations are so strong that adhesive cementation does not offer any additional mechanical advantages in comparison with conventional cementation for most indications. Inlay and Maryland bridges are exceptions to this (see Adhesive Cementation of Inlay and Maryland Bridges). Self-adhesive cementation with RelyX Unicem, manufactured by 3M ESPE: 8 Thoroughly clean the Lava Frame restoration and blast the interior surfaces of the crown with aluminum oxide 50 µm. 8 Please follow the Instructions for Use for the self-adhesive universal composite cement when processing RelyX Unicem. Adhesive Cementation with Composites: 8 Lava Frame restorations cannot be etched or silanized by direct application of a silane coupling agent. For adhesive cementation with composite cements, the adhesive surfaces must therefore be silicatized for 15 seconds with Rocatec Soft or CoJet Sand and silanized with ESPE Sil. 8 If the restoration is to be tried in, it must be done before the silicatization/silanization. See the Instructions for Use for Rocatec System or CoJet Sand for details about processing. 8 Place the restoration in the mouth with a composite cement, as soon as possible after silanization. All of the products mentioned in this chapter are manufactured by 3M ESPE. Adhesive Cementation of Inlay and Maryland Bridges: Inlay and Maryland bridges made of ceramic or Zirconia must be cemented adhesively using cements which have been expressly approved for these indications. Observe the cement manufacturers instructions for use concerning the pre-treatment of the tooth stump and of the ceramic. Generally speaking, there is an increased risk of decementation for inlay and Maryland bridges, which may result in loss of the restoration or to an increased risk of secondary caries. They must therefore be regarded as critical indications. During preparation, make sure that there is adhesion to the enamel and not to the dentin. The abutment teeth should therefore have slight enamel abrasions and adequate enamel surface for the attachment. Retentive elements should be prepared especially for Maryland bridges.adhesive cementing in general, but especially for Maryland and inlay bridges, must be done under a rubber dam and the cavity must be kept free of any contamination. The guidelines of the relevant national professional associations must also be observed for such indications. Removal of a Seated Lava Restoration 8 Use conventional rotating tools and adequate water cooling to introduce a slit and lift the restoration and/or common office instruments as an aid to pull off the restoration. 4

6 Lava DVS Digital Veneering System Product Description Lava DVS is used for production of glass ceramic veneers on Lava Frame Zirconia frameworks. The Lava DVS assortment consists of 4 glass ceramic blocks (E1-E4), from which the veneer is milled. Each ceramic block is available in the two sizes S and M. The veneer is then fused to the Zirconia framework via color-coordinated fusion porcelain (D1-D10). For smaller adjustments to the restoration, corrective porcelains (CR1-CR4) can be used. For the tooth colors A4, B4, C3, C4, and D4, the basic shades ( Shade A-D) must be used for color match. The individual stains S1 (White), S2 (Lemon Yellow), S3 (Orange), S4 (Violet), S5 (Blue), S6 (Dark Brown), and glaze are used for individualization. For the mixing of the fusion porcelain powder and the corrective porcelain, modelling liquid is available; also, for stains and glaze, stain/glaze liquid is available. Lava DVS blocks correspond to ISO 6872:2008 type II, class 1a. Lava DVS corrective porcelains, fusion porcelain, and stains correspond to ISO 6872:2008 type I, class 1a. CTE ( C): 9.2 +/ K-1. Temperature limit range: 540 +/-10 C. Color Combination Table Color Lava Frame Shade Dyeing Liquid DVS Block DVS Corrective Porcelain DVS Fusion Porcelain DVS Basic Shade Vita A1 FS1 E1 CR Vita A2 FS3 E2 CR Vita A3 FS3 E2 CR Vita A3,5 FS4 E4 CR Vita A4 FS4 E4 CR4 5 A Vita B1 FS1 E1 CR Vita B2 FS2 E2 CR Vita B3 FS5 E3 CR Vita B4 FS5 E4 CR4 7 B Vita C1 FS2 E2 CR Vita C2 FS6 E3 CR Vita C3 FS6 E3 CR3 9 D Vita C4 FS6 E4 CR4 9 C Vita D2 FS7 E1 CR Vita D3 FS7 E2 CR Vita D4 FS7 E3 CR3 9 D Additional Color W1 None E1 CR Additional Color W2 Additional Color W3 None E2 CR None E1 CR

7 For the production of a Lava DVS restoration, the Lava Frame Zirconia framework and the corresponding Lava DVS veneer are virtually designed on the screen. All of the above-mentioned Lava products are manufactured by or for 3M ESPE. The processing of Lava DVS is described in these Instructions for Use. Please also observe the operating instructions and instructions for use of the other products mentioned here when processing. These Instructions for Use should not be discarded for the duration of product use. Indications CAD/CAM veneering for anterior and posterior single crowns made of Lava Frame Zirconia Contraindications: CAD/CAM veneerings for restorations other than single crowns (i.e., bridges, inlays, onlays, veneers, or abutments) Veneering of single-tooth restorations for bruxist patients Precautionary Measures Precautionary Information for Patients This product contains substances that may cause an allergic reaction by skin contact in certain individuals. Avoid use of this product in patients with known Nickel allergies. Precautionary Information for Dental Personnel This product contains substances that may cause an allergic reaction by skin contact in certain individuals. To reduce the risk of allergic response, minimize exposure to these materials. In particular avoid exposure to product. If skin contact occurs, wash skin with soap and water. The use of protective gloves is recommended. If allergic reaction occurs, seek medical attention as needed. 3M ESPE MSDSs can be obtained at or from your local subsidiary. Designing and Milling the Framework and Veneer The Lava Frame Zirconia framework and die Lava DVS veneer are virtually designed. This can only be successful if sufficient space has been created by preparation. In order to be able to flawlessly mill the blanks as well as to attain a break-resistant restoration and an optimum color effect, the following design guidelines must be observed: o Minimum wall thicknesses for anterior teeth: Lava Frame 0.3 mm*, Lava DVS 0.6 mm* (* is a decisive factor in stability when milling), total: 0.9 mm. o Minimum wall thicknesses for posterior teeth: Lava Frame 0.5 mm*, Lava DVS 0.6 mm* (* is a decisive factor in stability when milling), total: 1.1 mm. o Maximum layer thickness of Lava DVS veneer: 1.5 mm (there is a risk of breakage when the veneer is too thick). o Optimum layer thickness on aesthetic grounds (based on previous experience): 1.1 mm-1.3 mm. Shaping 8 Shape the restoration with the standard diamond tools for ceramics and cut out the fissures. 8 After shaping, the indicated minimum total wall thickness must still be intact. 8 Clean or steam-clean under running water and dry with compressed air. Re-layering (if necessary) 8 Roughen the restoration or blast it with 50 µ aluminum oxide. 8 Re-layer fusion porcelain to the cervical area, if the veneer may have shrunk back from the edge: Re-moisten the fusion porcelain (as long as it is not yet dried out) with distilled water. Do not re-use any dried-out fusion porcelain. Layer, suck off, re-fire (firing procedure: corrective firing), and shape as customary the fusion porcelain. 6

8 8 Re-layer inter-dental or occlusion contacts: Mix a like-colored corrective porcelain (see Color Combination Table) with modelling liquid or distilled water. Then layer, vacuum up, and fire the corrective porcelain (firing procedure: corrective firing), and then shape. 8 Thoroughly clean the restoration under running water or steam-clean and dry with compressed air. Color Match In order to attain optimum coloration for the tooth colors A4, B4, C3, C4, and D4, the color of the DVS veneer must be adjusted with one of the basic shades A-D. 8 Select the suitable basic shade from the color combination table. 8 Mix the powder with stain/glaze liquid and then apply a thin layer of the paste to the restoration with a brush until the shade according to the shade guide is attained. 8 Fire the restoration (firing procedure: stain firing). Individualization and Glaze Firing The individual stains can be applied and fired along with the glaze. The glaze firing can be performed with or without glaze. 8 Mix the desired individual stains (S1-S6) and/or the glaze with stain/glaze liquid. 8 To individualize the restoration, use a brush to apply a thin layer of the paste(s) to the restoration until the desired individual characterization is attained. 8 Fire the restoration (firing procedure: stain firing). If individual stains are applied along with glaze, then use the firing program Glaze firing with glaze. Notes Standard veneer ceramics cannot be used for layering. Lava DVS may only be used as a veneer on Lava Frame Zirconia frameworks; use as a crown without the supporting Zirconia framework is not permissible. Lava DVS fusion porcelains, corrective porcelains, basic shades, individual stains, and glaze may only be used in combination with Lava DVS blocks; a combination with other ceramic porcelains (e.g., Lava Ceram) is not possible due to the difference in the thermal expansion value. 7

9 Lava Wax Block for Pattern Milling Product Description Lava Wax, manufactured by 3M ESPE, is a wax block for pattern milling used in the casting or pressing technique. Lava Wax does not leave behind any residue when fired. Please see the operating instructions for the specified products and the instructions for use for the material being used. These Instructions for Use should not be discarded for the duration of product use. Indications Preparation of wax frameworks for metal casting technique Preparation of wax patterns for press ceramic pressing technique Lava Wax is not intended for use in the patient s mouth. Precautionary Measures 3MESPE MSDSs can be obtained at or from your local subsidiary. Shaping the Wax Pattern The wall thicknesses and the connector cross-sections are decisive for the stability of the later restorations; hence, please comply with the specifications for the material being used. Casting the Wax Pattern 8 Pin and embed the wax pattern according to the specifications for the alloy or press ceramic which will be used. 8 As usual in cast/press technique, burn the wax out of the muffle in a pre-heating furnace using a suction device. Avoid inhaling the gases from the firing. 8 Cast or press the restoration according to the specifications of the alloy or press ceramic. Disposal 8 Dispose of the blank holder with the residual wax in the household rubbish. 8

10 Customer Information No person is authorized to provide any information that deviates from the information provided in this instruction sheet. Warranty 3M ESPE warrants this product will be free from defects in material and manufacture. 3M ESPE MAKES NO OTHER WARRANTIES INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. User is responsible for determining the suitability of the product for user s application. If this product is defective within the warranty period, your exclusive remedy and 3M ESPE s sole obligation shall be repair or replacement of the 3M ESPE product. Limitation of Liability Except where prohibited by law, 3M ESPE will not be liable for any loss or damage arising from this product, whether direct, indirect, special, incidental or consequential, regardless of the theory asserted, including warranty, contract, negligence or strict liability. Information valid as of July