ALLROUND-E (CODE NAME RD 1710) by J.F. JELENKO & CO., INC.

Allround E ( Code name: RD1710 ) is a platinum gray color, Copper free, palladium-silver, porcelain-to-metal alloy designed for low fusing porcelain in the market. It is a Noble alloy under Identalloy and ADA classification system for Dental alloy. It can also be used as Type-III crown and bridge alloy. It is suitable for single units, short--span bridge work and long span bridge work. Ideal for combination cases of PTM / PFM and Crowns.

Device Description

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental alloy named "Allround-E (Code Name RD 1710)". It does not contain information about acceptance criteria or a study proving that a device meets such criteria.

The letter explicitly states: "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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976."

This means the device was cleared based on its substantial equivalence to pre-existing, legally marketed devices, not through a study demonstrating it meets specific performance acceptance criteria.

Therefore, I cannot provide the requested information from the provided text as it is not present in the document.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 1999

Mr. Tridib Dasgupta Director R&D and Q.C J.F. Jelenko & Company, Incorporated 99 Business Park Drive Armonk, New York 10504

K984587 Re : Allround-E (Code Name RD 1710) Trade Name: Requlatory Class: II Product Code: EJS Dated: December 22, 1998 Received: December 24, 1998

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 legally marketed predicate 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 reqistration, 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. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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

{1}------------------------------------------------

Page 2 - Mr. Dasgupta

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral 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/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Direc cor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Page

510(k) NUMBER (IF KNOWN): K984587

DEVICE NAME: Allround E (Code Name: RD1710)

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use No OR Over-The-Counter-Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 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.