(69 days)
The UCC™ Dental Material is used as a bonding agent to facilitate a bond between an opaque resinous veneering material and a gold based metal understructure in the preparation of a Resin-Fused-to-Metal-Restoration (RFM). The UCC™ Dental Material is particularly intended for bonding veneering material to a precious metal coping marketed under the trade name "Captek" which received Premarket 510(K) authorization from the FDA in 1994 under the FDA number K932243 HF-2-410 ODE/DGRD.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a dental material (UCC™ Dental Material). It confirms substantial equivalence to a predicate device but does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details related to the efficacy or performance testing of the device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the provided text. The document focuses solely on the regulatory approval process based on substantial equivalence, not on a detailed performance study.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2003
Mr. Eugene Lieberstein, Esq. Secretary Precious Chemicals U.S.A., Incorporated 2151 Long Ridge Road Stamford, Connecticut 06903
Re: K023790
Trade/Device Name: UCC™ Dental Material Regulation Number: 21 CFR 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: November 08, 2002 Received: November 13, 2002
Dear Mr. Lieberstein:
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. Eugene Lieberstein, Esq.
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. 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) you may obtain. 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,
Susan Runner
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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PRECIOUS CHEMICALS U.S.A., INC Premarket 510(k) Submission UCC™ Dental Material Requiatory Class II
Indication Of Use Statement
The UCC™ Dental Material is used as a bonding agent to facilitate a bond between an opaque resinous veneering material and a gold based metal understructure in the preparation of a Resin-Fused-to-Metal-Restoration (RFM). The UCC™ Dental Material is particularly intended for bonding veneering material to a precious metal coping marketed under the trade name "Captek" which received Premarket 510(K) authorization from the FDA in 1994 under the FDA number K932243 HF-2-410 ODE/DGRD.
Kein Mulay for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K023790
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.