(95 days)
The indicated usage for this product is as a ceramic alloy for use in the construction of ceramic single unit crowns Fixed Restorations.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a dental ceramic alloy. It does not contain information regarding acceptance criteria for a device's performance, nor does it describe a study that proves the device meets such criteria.
The document states that the device, "BIO-97," is a "ceramic alloy for use in the construction of ceramic single unit crowns Fixed Restorations." However, it does not provide any performance metrics, study designs, sample sizes, or ground truth details.
Therefore, I cannot fulfill the request for information about acceptance criteria or a study proving device performance based on the input provided. The document is largely administrative, confirming the device's substantial equivalence to previously marketed devices and outlining regulatory obligations.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles facing to the right, stacked on top of each other.
Public Health Service
SEP 7 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Murray G. Gamberg Assistant Vice President of Quality Assurance Jeneric/Pentron, Incorporated 53 North Plains Industrial Road Wallingford, Connecticut 06492-0724
Re: K991901 BIO-97 Trade Name: Regulatory Class: II EJT Product Code: Dated: August 5, 1999 Received: August 13, 1999
Dear Mr. Gamberg:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ 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 requlation 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 obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Gamberg
the Act for devices under the Electronic Product Radiation che net ror devels or other Federal laws or regulations.
This letter will allow you to begin marketing your device as Info recei will and many of the motification. The FDA debtition in your tial equivalence of your device to a legally Finding of Subbeaneral Squaraults in a classification for your markeed predicaloremits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in regulacion (sic devices), please contact the Office of Compliance at (301) 594-4692. 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 the regulation entreleca, "Hibblanding by Socher general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at at feb corr free namblettp://www.fde.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
hy A. Ulatow 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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Image /page/2/Picture/0 description: The image shows a sequence of characters, seemingly handwritten or stylized. The sequence reads as 'K991901'. The characters are bold and black, set against a white background, giving a high contrast. The style of the characters suggests a casual or informal script.
Page 4
INDICATIONS
510(k) Number (if known):
KaaRol
Device Name: Bio -97
Indications For Use:
The indicated usage for this product is as a ceramic alloy for use in the construction of ceramic single unit crowns Fixed Restorations.
Prescription DEVICE
Suren Panne
(Division Sign-Off) (Division of Dental, Infection Control,
Division of Dental, Infection Devices . . . . . . . Division of Despital D 510(k) Number
§ 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.