(37 days)
The Amelogen plus is a tooth shade resin composite material [bisphenol-A, glycidy] methacrylate (Bis-GMA) based] to be used for posterior and anterior tooth restoration.
Not Found
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a dental resin material named "Amelogen Plus." It confirms the device's substantial equivalence to a predicate device but does not detail any performance study, acceptance criteria, or related metadata.
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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2004
Ms. Tammy Lavery Senior Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095
Re: K043119
Trade/Device Name: Amelogen Plus Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 9, 2004 Received: December 13, 2004
Dear Ms. Lavery:
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 (1 11 ), it an 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 Eederal Register.
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Page 2 - Ms. Lavery
Please be advised that FDA's issuance of a substantial equivalence determination does not I Teast be auvrood that I Dr a loomination that your device complies with other requirements mean that I Dr I has made statutes and regulations administered by other Federal agencies. of the Act of ally 1 ederal bulance and equirements, including, but not limited to: registration 1 ou interest comply was a 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF rear on 1), a may on the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in one of 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) I mis rettor wification. The FDA finding of substantial equivalence of your device to a premaired notified.com - 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), r you desire spleine arrow 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 maj ovean 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/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
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
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INDICATIONS FOR USE
Ko43119 510(k) Number (if known): __Unknown
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Amelogen plus is a tooth shade resin composite material [bisphenol-A, glycidy] methacrylate (Bis-GMA) based] to be used for posterior and anterior tooth restoration.
Prescription Use Dentist Administered (Per 21 801 CFR Subpart D)
AND/OR
Over-The-Counter Use_ (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
ിvision Sıgn-Off) (Division Sign-Off)
Olvision of Anesthesiology, General Hospital,
Division of Anesthesioners, Ulvision of Anton Control. Devices
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Page 1 o (Posted November 13, 200)
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.