NEXCOMP AND META ETCHANT

{0}------------------------------------------------ K080305 510(k) SUMMARY (Nexcomp) APR - 7 2008 Submitter: Tae-Hoon Kim, Manager QM, Meta Biomed Co., Ltd. Cheongwongun Chungbuk, Korea. Tel: 82-43-218-1983. Classification Name and Number: Tooth Shade Resin Material, Class II, EBF. Common/Usual Name: Composites, restoratives. - 1. Proprietary Name: Nexcomp - II. Registration No .: 9681254 - lll. Compliance with Performance Standards: Nexcomp complies with ISO 4049:2000(E), Polymer-based filling, restorative, and luting materials. Also, followed "Guidance for Industry and FDA Staff; Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions" - IV. Description of the Device: Nexcomp is a highly filled (75 wt.%), light-cured hybrid composite. The material is radiopaque and indicated for all types of cavity preparations. The hybrid blend has an ultra fine filler and 40 nm silica particles. Nexcomp will be marketed in incisal, body translucent, and body opaque shades which correspond with the Vita shade guide. Nexcomp bonds micromechanically and chemically to prepared tooth surfaces, dental primers and bonding resin adhesives through copolymerization of its air-inhibited layer. It's color can be matched with various shades of standard color quides. It is available in tubes which are designed to be fitted into a screw-syringe with a body cap seal. - V. Labels and Labeling: Draft labels of Nexcomp and instructions for use are provided, together with warnings and contra-indications. - VI. Substantial Equivalence: These devices are equivalent to devices manufactured and sold before 1976, having a U. S. classification number (code) EBF, and those described under 21 CFR 872.3690. Each is also equivalent to several devices currently on the market that have been cleared by the premarket notification-510(k) process. Some of these are outlined below: - 1. K070583, Nano Composite, Cosmedent, Inc., XI. {1}------------------------------------------------ - 2. K052097, Ceram X Universal Mano-Ceramic Restorative, Dentsply, Inc. - 3. K003361, Renew LS-2, Bisco, Inc., - 4. K982729, Renew, Bisco, Inc. The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed. (End of Summary) {2}------------------------------------------------ K080305 APR - 7 2008 ## 510(k) SUMMARY (Meta Etchant) Submitter: Tae-Hoon Kim, Manager QM, Meta Biomed Co., Ltd, Cheongwongun Chungbuk, Korea. Tel: 82-43-218-1983. Classification Name and Number: Tooth Shade Resin Material, Class II, EBF. Common/Usual Name: Etching gel. - Proprietary Name: Meta Etchant. 1. - 11. Registration No.: 9681254 - Compliance with Performance Standards: There appear to be no III. applicable standards for etching gels, however, we followed "Guidance for Industry and FDA Staff; Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions". - IV. Description of the Device: Meta Etchant is a thickened, colored, phosphoric acid semi-gel designed to prepare tooth surfaces (dentin and enamel) for application of a bonding agent, cementation, or restorative materials. - Labels and Labeling: Draft labels of Meta Etchant and instructions for use V. are provided, together with warnings and contra-indications. - Substantial Equivalence: These devices are equivalent to devices VI. manufactured and sold before 1976, having a U. S. classification number (code) EBF, and those described under 21 CFR 872.3690. Each is also equivalent to several devices currently on the market that have been cleared by the premarket notification-510(k) process. For Meta Etchant, some predicates are: - 1. K062409. K-Etchant Gel, Kuraray Medical Inc., - 2. K022492, Pulpdent Semi-Gel Etch, Pulpdent Corporation, The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed. (End of Summary) XI. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Tac-Hoon Kim QM Manager Meta Biomed Company, Limited 441-12 Mo Choong Dong Cheong Ju Cheong City, Chung Buk REPUBLIC OF KOREA APR - 7 2008 Re: K080305 Trade/Device Name: Nexcomp and Meta Etchant Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Regulatory Class: Il Product Code: EBF, KLE Dated: January 19, 2008 Received: January 5, 2008 Dear Mr. Kim: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {4}------------------------------------------------ Page 2 - Mr. Kim Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Suitty Y. Mccleese Ows. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## X.1 Indications for Use: [Separate Page] Kogo 305 510(k) Number: 😍ጅ Device Name: Meta Etchant Indications for use: Meta Etchant is intended for use in dentin/enamel etching to prepare the tooth surface for application of a bonding agent. Prescription Use × (Per 21 CFR 801 Subpart D) OL Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 9 Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Ruoppner (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K080305 {6}------------------------------------------------ ## X. Indications for Use: [Separate Page] 16080305 510(k) Number: MA Device Name: Nexcomp Indications for use: Nexcomp is intended to restore carious lesions or structural defects in teeth. It is indicated for Class I, II, IV, and V restorations, core-buildup to replace missing tooth structure, for splinting and for diastema closure, direct veneers, composite and porcelain repairs. Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED 8 or Concurrence of CDRH, Office of Device Evaluation (ODE) Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices 10(k) Number. KCSOBCS