(44 days)
Direct restoration of Class I-V cavities Direct composite veneers Shape corrections of teeth Temporary splinting of teeth loosened by trauma or periodontal disease Indirect restorations Restoration of primary teeth Core build-up Temporary repairs of porcelain, composite
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The provided text is a 510(k) premarket notification letter from the FDA regarding a dental product, "Venus Universal Light Curing Composite." It primarily concerns the regulatory approval process and does not contain the kind of detailed study information (acceptance criteria, performance data, sample sizes, ground truth establishment, expert qualifications, etc.) that you've asked for.
This document is a notification of substantial equivalence, meaning the FDA has determined the new device is as safe and effective as a legally marketed predicate device. It doesn't typically include a scientific study report with specific performance metrics and methodologies.
Therefore, I cannot extract the information requested from the provided text.
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Image /page/0/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized eagle emblem, with three parallel lines forming the upper part of the eagle's body and wing. The lower part of the eagle is represented by curved lines, suggesting feathers or the lower body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2002
Ms. Cheryl V. Zimmerman Manager, Quality Operations and Compliance Heraeus Kulzer, Incorporation 4315 South Lafayette Boulevard South Bend, Indiana 46614-2517
Re: K020131
Trade/Device Name: Venus Universal Light Curing Composite Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: January 11, 2002 Received: January 15, 2002
Dear Ms. Zimmerman:
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.
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.
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Page 2 - Ms. Cheryl V. Zimmerman
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if Known):
Device Name: Venus Universal Light Curing Composite
Indications For Use:
Direct restoration of Class I-V cavities Direct composite veneers Shape corrections of teeth Temporary splinting of teeth loosened by trauma or periodontal disease Indirect restorations Restoration of primary teeth Core build-up Temporary repairs of porcelain, composite
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109) OR
Over-The-Counter Use_
wivery, Wagon (Tivision Sign-Off)
് സ്വടനാ വില്ലാ Portshin of Boneral Hospital Devices
For General Hospital Devices
Nomber -----------------------------------------------------------------------------------------------------
(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.