BEGOCER G by BEGO U.S.A. | FDA 510(k) Summary

BegoCer G is a crown and bridge metal to ceramic type 4 alloy. It is a medical device in Degood of is a crown and enegal Class Ha according to Annex IX.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental alloy named BegoCer® G. It confirms that the device is substantially equivalent to a legally marketed predicate device.

Based on the provided text, it is not possible to describe acceptance criteria or a study that proves the device meets those criteria.

The document is a clearance letter, which means the device has already gone through the review process and been deemed substantially equivalent. It does not contain the detailed study information, acceptance criteria, or performance data that would typically be part of a submission to demonstrate safety and effectiveness.

Here's what can be inferred/answered based solely on the provided text, and what cannot be answered:

Information from the document:

Device Name: BegoCer® G
Device Type: Crown and bridge metal to ceramic type 4 alloy.
Regulatory Class: Class IIa (according to Annex IX) / Class II (as stated by FDA in the letter).
Indications For Use: "BegoCer G is a crown and bridge metal to ceramic type 4 alloy. It is a medical device..." (The rest of the sentence is cut off in the image but the core indication is clear).
510(k) Number: K983082
Date of Clearance: October 28, 1998
Manufacturer: BEGO U.S.A., Incorporated

Information NOT present in the document:

The provided text does not contain any information regarding:

A table of acceptance criteria and the reported device performance. This is a clearance letter, not the study report itself.
Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size. This type of study is more common for diagnostic imaging AI, not for a dental alloy's mechanical properties.
If a standalone performance study was done.
The type of ground truth used. (e.g., expert consensus, pathology, outcomes data, etc.)
The sample size for the training set. (Dental alloys typically don't involve "training sets" in the AI sense; their performance is evaluated through material science testing.)
How the ground truth for the training set was established.

Conclusion:

The provided FDA 510(k) clearance letter indicates that the BegoCer® G device was found substantially equivalent to a predicate device. However, it does not include the detailed study information, acceptance criteria, or performance data that would have been part of the original 510(k) submission. To answer the specific questions about acceptance criteria and study details, one would need to review the original 510(k) submission (K983082), which is not provided here.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The eagle faces right and is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 8 1998

Mr. William J. Oremus General Manager BEGO U.S.A., Incorporated 1088 Main Street, Suite 200 Pawtucket, Rhode Island 02860

Re : K983082 BegoCer® G Trade Name: Regulatory Class: II Product Code: EJT Dated: Auqust 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, 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. ਕ 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 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 regulations.

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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 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.

Clator

Timothy A. Ulatowsk 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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K983082 510(k) Number (if known): BegoCer G Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

BegoCer G is a crown and bridge metal to ceramic type 4 alloy. It is a medical device in Degood of is a crown and enegal Class Ha 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)

	(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	4983082

Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use ______
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(Optional Format 1-2-96)------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Regulation Number and Section

§ 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.