JEL BIOS 10 (CODE NAME RD-1801) by J.F. JELENKO & CO., INC.

High Gold and Platinum containing ceramic alloy for porcelain to metal restorations. It is Palladium, Silver and copper free dental alloy with less than 2.0 % base metal. Jel bios 10 is a rich gold color hard gold base alloy with high yield strength and thermal stability. It is compatible with a wide range of porcelain available in the market. It can be used for porcelain to metal fabrication of single units and all bridge work including single and three or four crowns.

Device Description

AI/ML Overview

I am sorry, but since the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental alloy, it does not contain information about the acceptance criteria and study details for a device's performance as would be found in a clinical study report. The letter confirms substantial equivalence to a predicate device but does not include the specifics of performance testing.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1999

Mr. Tridib Dasqupta Director R&D J.F. Jelenko & Co. Jelenko Dental Health Products 99 Business Park Drive Armonk, New York 10504

Re : K993136 Trade Name: Jel Bios 10 (Code Name RD-1801) Regulatory Class: II Product Code: EJT Dated: September 13, 1999 Received: September 20, 1999

Dear Mr. Dasgupta:

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 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 (Premarket Approval), 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 895. ਬੈ 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

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Page 2 - Mr. Dasgupta

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.

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 regulation (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 ene 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,

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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Image /page/2/Picture/0 description: The image shows the text "K993136" in a bold, sans-serif font. Below the numbers, the words "Page" and "of" are printed in a smaller font size. There are blank lines after the words "Page" and "of", presumably for writing in page numbers.

unknown. K993136 510(k) Number (if known):

Jel Bios 10 ( Code Name RD-1801 ) Device Name:

Indications For Use:

Jri Dis Dong A

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

yes Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use No.

(Optional Format 1-2-96)

Division of Dental, Infectio and General Hospital I 510(k) Number

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.