Annex II (excluding section 4) of Council Directive 93/42/EEC concerning medical devices

Transcription

1 Full Quality Assurance System Approval Certificate Annex II (excluding section 4) of Council Directive 93/42/EEC concerning medical devices Scope of Certificate: Design and Manufacture of Stainless Steel Brackets, Orthodontic Buccal Tubes, Orthodontic Bands, Fixed & Functional Products, Stops & Hooks, Composite (Plastic) Brackets, Ceramic Brackets, Elastomeric Products, Orthodontic Wire Products, Lingual Attachments, and Orthodontic Wire Springs. Device Classifications: Class IIa Device Descriptions and Model Type: Please refer to Attachments: 1, 2, 3, 4, 5 We hereby declare that an examination of the full quality assurance system has been carried out following the requirements of the national legislation to which the undersigned is subject, transposing Annex II (with the exemption of section 4) of Council Directive 93/42/EEC on Medical Devices. We certify that the full quality assurance system conforms with the relevant provisions of the aforementioned directive and is subject to periodic surveillance as required by 93/42/EEC. Annex II, Section 5. For Class III devices where they are covered by this certificate, an EC Design Examination certificate according to 93/42/EEC, Annex II, Section 4 is required. This certificate is issued with 5 attachments listing product references covered by this certificate. Medical Operations Manager

2 Attachment 1 of 5 Lingual Attachments Orthodontic Clamp, Wire Buttons Class IIa Ball Hooks Class IIa Lingual Sheaths Class IIa Eyelets Class IIa Coil Eyelet Class IIa Low Profile Cleats Class IIa Gull Wing Cleats Class IIa Elastic Lugs Class IIa Seating Lugs Class IIa Bands Orthodontic Band, Material Band Material Class IIa Ceramic Brackets Self-Ligating Orthodontic Bracket Empower Clear Class IIa Orthodontic Bracket, Ceramic Radiance Plus Class IIa Composite Brackets Orthodontic Bracket, Plastic, Single- Use Silkon Plus Class IIa Elastomerics Orthodontic Band, Elastic The Wildlife Series Class IIa Sea Life Elastics Class IIa Colored Chain Class IIa Memory Chain Class IIa Orthodontic Archwire/Bracket Ligature Ligatures Class IIa Stops and Hooks Orthodontic Clamps/Locks/Hooks Weldable Stop Class IIa Surgical Hook Class IIa Medical Operations Manager

3 Attachment 2 of 5 Stops and Hooks Orthodontic Clamps/Locks/Hooks Arch Hook Class IIa Arch Lock Class IIa Monkey Hook Class IIa Buccal Tubes Orthodontic Tubes Empower Class IIa Empower 2 Class IIa Mini Master Series Class IIa Master Series Class IIa ifit Class IIa LP Low Profile Class IIa Slim Tube Class IIa Cross Tubes Class IIa Piggyback Tubes Class IIa Dr. Korn Tube Class IIa Inconel Class IIa Funneled Entrance Class IIa Non Convertible Class IIa Non Convertible Double Class IIa Non Convertible Triple Class IIa Non Convertible Lip Bumper Class IIa Non Convertible WRAPAROUND Class IIa Medical Operations Manager

4 Attachment 3 of 5 Buccal Tubes Orthodontic Tubes Convertible Single Class IIa Convertible Double Class IIa Convertible Triple Class IIa Nola Buccal Tube Class IIa DB Tube Gold Class IIa Fixed & Functional Orthodontic Appliance System, Adjustable Distal Jet Class IIa Spring Jet Class IIa Mesial Jet Class IIa Uprighter Jet Class IIa Jasper Jumper Class IIa Gentle Jumper Class IIa Jones Jig Class IIa Rapid Molar Intruder Class IIa M.A.P. Mini Activator Class IIa Posturer Mandibular Advancer Class IIa Quick Fix Class IIa Lip Bumper Class IIa Cantilever Bar Offset Class IIa Hanks Telescoping Herbst Class IIa Miniscope Telescoping Herbst Class IIa Medical Operations Manager

5 Attachment 4 of 5 Fixed & Functional Orthodontic Appliance System, Adjustable Orthodontic Space Maintainer Herbst Appliance Class IIa Powerscope 2 Class IIa Alexander Lip Bumper Class IIa Bondable Space Maintainer Class IIa Bondable Retainer Class IIa (Alexander Flat Bow Retainer , 156, 157) Orthodontic Retainer Bondable Retainer Class IIa Bite Blocks Class IIa Tongue Director Class IIa Diastema Class IIa Orthodontic Wire Orthodontic Wire Tanzo Class IIa NT3 Class IIa Superelastic Titanium Class IIa Memory Everwhite Wire Class IIa Wrap Around Hawley Class IIa Retainer Multiphase Blue Chromium Class IIa Cobalt Wire Orthodontic Ball Retainer Clasps Class IIa Archwire/Bracket Ligature Ligature Wire Class IIa Stainless Steel Brackets Orthodontic Bracket, Metal LP Low Profile Class IIa Empower 2 Class IIa Mini Master Series Class IIa Medical Operations Manager

6 Attachment 5 of 5 Stainless Steel Brackets Orthodontic Bracket, Metal Master Series Class IIa T3 Class IIa Mini Standard Edgewise Class IIa Mini Tweed Class IIa Iconix Class IIa Forever Gold 24K Class IIa Metal Custom Rx Class IIa Stealth Lingual Class IIa Bands Orthodontic Band, Preformed MRX Bands Class IIa MR Class IIa MR1 Class IIa MR2 Class IIa MR3 Class IIa Contoured Class IIa Rollo Bands Class IIa Anteriors Class IIa Mini Skirt Crowns Class IIa Stops and Hooks Orthodontic Clamps/Locks/Hooks Power Hook Class IIa Crimpable Stop Class IIa Medical Operations Manager