(49 days)
Versa-Link Porcelain Bonding System is indicated for the adhesive cementation/bonding of all-ceramic dental restorations (veneers, inlays, onlays and crowns) composed of feldspathic porcelain, pressed porcelain and in-office machined ceramics.
A secondary indication is for the adhesive repair of fractured or damaged metal-ceramic units intraorally.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a dental bonding system. It does not contain any information about the acceptance criteria, study details, or performance evaluation of a device as requested in the prompt.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
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Image /page/0/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center consists of three curved lines that resemble a stylized bird or abstract design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2005
Clark Smith, DDS Senior Vice President Sultan Chemists, Incorporated 85 West Forest Avenue Englewood, New Jersey 07631
Re: K052699
Trade/Device Name: Versa-Link® Porcelain Bonding System Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 14, 2005 Received: November 03, 2005
Dear Dr. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becare on (--) } }
referenced above and have determined the device is substantially equivalent (for the indications for referented in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass backed in also increat date of the Medical Device Amendments, or to devices that provision in the first of any and 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 therefore, manier and from the 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 If your as nee is one morely. Existing major regulations affecting your device can be may be subject to been as 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 - Clark Smith, DDS
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" (21 CFR 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,
Sylette y. Michael Dms.
Chiu S. Lin, PhD 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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Statement of Indications For Use
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number: L052699
Device Name: Yersa-Link Porcelain Bonding System
Indications For Use:
Versa-Link Porcelain Bonding System is indicated for the adhesive cementation/bonding of all-ceramic dental restorations (veneers, inlays, onlays and crowns) composed of feldspathic porcelain, pressed porcelain and in-office machined ceramics.
A secondary indication is for the adhesive repair of fractured or damaged metal-ceramic units intraorally.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Prescription Use
(Per 21 CFR 801.109)
Over-the-Counter Use _
Susan Runne
. Sion Sign-Off) Colon of Anesthesiology, General Hospital. Intection Control, Dental Devices
Number: K052189
4 - 1
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.