(28 days)
COLORISE RIGID is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material intended to be placed on a preformed impression tray and used to reprocluce the structure of a patient's teeth and gums.
COLORISE RIGID is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material.
I am sorry, but based on the provided text, I cannot provide details on the acceptance criteria and the study that proves the device meets those criteria.
The document is a 510(k) premarket notification letter from the FDA to Zhermack S.p.A. for their device named "COLORISE RIGID". This letter primarily states that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
While it mentions the device is an "impression material" and "intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums," the document does not contain any information regarding:
- Specific acceptance criteria for the device's performance.
- Details of any study conducted to demonstrate the device meets acceptance criteria.
- Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
- Whether MRMC or standalone performance studies were done.
- The type of ground truth used or how ground truth for training data was established.
This document is an administrative approval letter, not a scientific study report or a detailed technical specification.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2008
Zhermack S.p.A. C/O Mr. Gerald W. Shipps Regulatory Affairs Consultant Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702
Re: K081084 Trade/Device Name: COLORISE RIGID Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: April 14, 2008 Received: April 17, 2008
Dear Mr. Shipps:
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. Shipps
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 promarket 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,
Ove
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
510(k) Number (if known):
Device Name: COLORISE RIGID
Indications for Use: COLORISE RIGID is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material intended to be placed on a preformed impression tray and used to reprocluce the structure of a patient's teeth and gums.
Prescription Use V
AND/OR
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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDELL)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suan Runner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: YC081051
COLORISE RIGID Rev. 0 April 10, 2008 Page 1 of 1
Zhermack SpA - Via Bovazecchino, 100 - 45021 Badia Polesine (Rovigo) Italy - tel. +39 0425 597611 - fax +39 0425 53596
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§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).