(51 days)
BegoPal is a crown and bridge metal to ceramic type 4 alloy. It is a medical device in accordance with 93/42 EEC. Class IIa according to Annex IX.
BegoPal is a crown and bridge metal to ceramic type 4 alloy.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that demonstrates a device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a dental alloy named BegoPal, indicating its substantial equivalence to a predicate device. It discusses regulatory matters such as classification, general controls, and marketing authorization.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study based on the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 1998
Mr. William J. Oremus General Manager BEGO U.S.A., Incorporated 1088 Main Street, Suite 200 Pawtucket, Rhode Island 02860
Re : K983078 Trade Name: BeqoPal® Regulatory Class: II Product Code: EJS Dated: August 17, 1998 September 2, 1998 Received:
Dear Mr. Oremus:
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, 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 (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. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Oremus
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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 premarket notification" (21 CFR 807.97). Other 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 its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricia Cresente Hoc
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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K983078 510(k) Number (if known): BegoPal
Device Name:
Indications For Use:
BegoPal is a crown and bridge metal to ceramic type 4 alloy. It is a medical device in Degor an is a crown and one93/42 EEC. Class IIa according to Annex IX.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Heral Skipp
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.