JEL BIOS 18 (CODE NAME RD- 1214) by J.F. JELENKO & CO., INC.

Jel Bios 18 is a high Platinum containing Gold base ceramic alloy for porcelain to metal restorations. It has light yellow color and due to high Platinum content this alloy offers excellent thermal stability. It is suitable for long span bridges. It is compatible with most of the porcelains available in the market. It can be used for full crown and also for porcelain to metal restoration of single and three to four crown bridges.

Device Description

AI/ML Overview

I am sorry, but based on the provided document, I cannot extract the acceptance criteria and study information you requested. The document appears to be an FDA 510(k) clearance letter for a dental alloy, "Jel Bios 18." It confirms substantial equivalence to pre-amendment devices and outlines regulatory obligations, but it does not detail:

Acceptance Criteria or Device Performance: There is no table or description of specific performance metrics or thresholds for the device.
Study Design Information: The document does not mention any studies conducted to prove the device meets acceptance criteria, nor does it provide details about sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone study results.
Training Set Information: No information regarding a training set for an AI/algorithm is present, as this appears to be a material device clearance.

The document's focus is on the regulatory clearance of a physical medical device (dental alloy), not a software or AI-driven device that would typically involve the type of study and performance metrics you've asked about.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three wavy lines that resemble a caduceus or a representation of human figures.

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: K993152 Trade Name: Jel Bios 18 (Code Name RD-1214) Requlatory Class: II Product Code: EJT September 13, 1999 Dated: Received: September 21, 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 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. 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 Druq 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

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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 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,

K. Celotauk

Timothy A. Celotowski

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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K993152

. r. c

99 BUSINESS PARK DRIVE. ARMONK. NEW YORK U.S.A. 10504 • (914) 273-8600 F A X: ( 9 1 4 ) 2 7 3 - 9 3 7 9

Page of

novon. 11993152 510(k) Number (if known):

Jel Bios 18 ( Code Name : RD-1214 ) Device Name:

Indications For Use:

Jridh Dargupta

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Armor

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

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

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.