(100 days)
USED AS A Composite RESTORATIVE to REPAIR CARIOUS LESIONS MATERÍAL FOR VENEERING. AND DoTASSIum CONTA
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria for a device, a study that proves a device meets such criteria, or any of the detailed aspects like sample sizes, expert qualifications, or ground truth establishment.
The document is a 510(k) clearance letter from the FDA for a device named "Composite Restoration Material." This letter primarily addresses:
- Device Name: Composite Restoration Material
- Regulation Number/Name: 872.3690 / Tooth Shade Resin Material
- Regulatory Class: II
- Product Code: EBF
- FDA Determination: Substantially equivalent to legally marketed predicate devices.
- Conditions: The device can be marketed subject to general controls (registration, listing, GMP, labeling, etc.).
- Indications for Use: Used as a Composite Restorative to repair carious lesions, material for veneering.
This type of document confirms that the device is substantially equivalent to existing devices and can be marketed. It does not contain the results of a performance study with acceptance criteria, performance metrics, or details about the study design or data used to demonstrate those metrics. Therefore, I cannot provide the requested table or answer the specific questions about a study from the given text.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head with three curved lines above it, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol.
Public Health Service
SEP 1 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Milton Hodosh Milton Hodosh, D.M.D. 243 Elmwood Avenue Providence, Rhode Island 02907
Re: K031721
Trade/Device Name: Composite Restoration Material Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: May 29, 2003 Received: June 16, 2003
, :
Dear Dr. Hodosh:
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.
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Page 2 -Mr. Hodosh
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 (OS) 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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
Susan Runnes
Susan Runner, DDS, MA Interim 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
Page of
S ! (k) Number (if known): ENTAL ComposiTE RESTURATIVE Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use:
USED AS A Composite RESTORATIVE to REPAIR CARIOUS LESIONS MATERÍAL FOR VENEERING. AND DoTASSIum CONTA
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF NEEDED)
Rei Mueln Sor MSN
Division Sion of Anesthesiolo Infe ontrol, De
510(k) Number: K031721
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
§ 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.