(85 days)
- Identification: A base metal alloy is a device composed of a material such as a mixture of Nickel and Chromium
- Intended Use: This material is to be used by the dentist in the fabrication of a custom-made dental device, such as a porcelain veneer for a tooth.
- Classification: Class II
Hi Bond Non-Precious Ceramic Alloy is a base metal alloy composed of a material such as a mixture of Nickel and Chromium.
The provided text is a 510(k) clearance letter from the FDA for a dental alloy, specifically "Hi Bond Non-Precious Ceramic Alloy." This document does not contain any information about acceptance criteria, device performance studies, or clinical trial data.
The letter is a regulatory document confirming that the device is "substantially equivalent" to devices already on the market, which is a different concept than providing evidence of performance through a study described in the prompt's request.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence, not on specific performance metrics or studies as outlined in your prompt.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 1999
Mr. Paul L. Saxton Manager Education and Technical Service Matech, Inc. 13010 San Fernando Road Sylmar, CA 91342
K992881 Re : Hi Bond Non-Precious Ceramic Alloy Trade Name: Requlatory Class: II Product Code: EJH Dated: Undated Received: August 26, 1999
Dear Mr. Saxton:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Mr. Saxton
obligation you might have under sections 531 through 542 of obligation you might have the Electronic Product Radiation
the Act for devices under the Electronic Productions the Act for devices under the breakers or regulations.
This letter will allow you to begin marketing your device as t This letter will allow you conrest motification. The FDA described in your SFUN, prematios of your device to a legally finding of substancial equivalence of for your with marketed predicate device rebares in spoceed to the market.
If you desire specific advice for your device on our labeling II you desire specific additionally 809.10 for in regulation (21 on vices), please contact the Office of villo diagnostic devices), proads othonally, for questions on Compilance at (501) 531 ising of your device, please contact che promotion and adversible go also, Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to premation on your responsibilities under the Act may be Intormation on your responsible manufacturers Assistance oblained from the bivibion of 630-2041 or (301) 443-6597 or at i at Its coll-free hamber (o://www.fda.gov/cdrh/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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Matech, inc.
(818) 367-2472 (800) 292-6620 Fax: (818) 367-7059
13010 San Femando Rd., Sylmar, CA 91342, U.S.A.
Document #: B 045935
K992881 510 (k) Number (if known): . Device Name: Hi Bond Non-Precious Ceramic Alloy 510 (k) Request Matech, Inc.
Indications For Use:
- Identification: A base metal alloy is a device composed of a material such as a Amixture of Nickel and Chromium
- Intended Use: This material is to be used by the dentist in the fabrication of Ba custom-made dental device, such as a porcelain veneer for a tooth.
- C-Classifcation: Class II
Sincerely,
Paul Leslator
ul L. Saxton Manager Matech, Inc. 13010 San Fernando Rd. Sylmar, Ca 91342
(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
(Optional Format 1-2-96)
Susan Runa
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number _
§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is 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.