(129 days)
Jelfine-52 ( RD-0901 ) is a high noble alloy under Identalloy and ADA classification system for Dental alloy. It is designed for porcelain application ( PFM-alloy ) and compatible with most of the porcelain in the market. Jelfine-52 exhibits similar physical and thermal properties like Jelenko's "Olympia" and it provides quality restorations with rich platinum color. It polishes to a high luster. This high noble alloy is copper and silver free. Jelfine-52 provides accurate margins and it is perfect for single, 3 to 4 crowns and long span bridges.
Jelfine-52 ( RD-0901 ) is a high noble alloy under Identalloy and ADA classification system for Dental alloy. It is designed for porcelain application ( PFM-alloy ) and compatible with most of the porcelain in the market. Jelfine-52 exhibits similar physical and thermal properties like Jelenko's "Olympia" and it provides quality restorations with rich platinum color. It polishes to a high luster. This high noble alloy is copper and silver free. Jelfine-52 provides accurate margins and it is perfect for single, 3 to 4 crowns and long span bridges.
The provided text is a 510(k) premarket notification FDA letter from 1998 for a dental alloy named JELFINE-52. This type of document is a regulatory approval for a medical device and does not contain information about a clinical study with acceptance criteria and device performance as typically understood for software AI/ML devices.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the manufacturer demonstrated that their new device is as safe and effective as another legally marketed device, and therefore does not require new efficacy studies.
Therefore, I cannot fulfill your request for information on acceptance criteria and a study that proves the device meets those criteria, as this information is not present in the provided document. The questions you've asked are typically relevant for AI/ML medical devices undergoing de novo or PMA pathways, or 510(k)s that include detailed performance studies, which is not the case here.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 1998
Mr. Tridib Dasqupta Director R & D and Q.C J.F. Jelenko & Company, Incorporated 99 Business Park Drive Armonk, New York 10504
Re : K981257 JELFINE-52 (Code Name RD-0901) Trade Name: Requlatory Class: II Product Code: ESS Dated: July 14, 1998 Received: July 16, 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 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 Requlations, Title 21, Parts 800 to 895. - A -- -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 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
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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 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"(21CFR 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/dsma/dsmamain.html".
Sincerely yours,
A. Sutron for
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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DRIVE , ARMONK . NEW YORK U.S.A. 10504 . ( 9 1 4 ) 2 7 3 - 8 6 0 0 FAX: ( 9 1 4 ) 2 7 3 -
Page of
510(k) Number (if known): K981257
Device Name: JELFINE-52 (RD-0901)
Indications For Use:
(Per 21 CFR 801, 109)
Jelfine-52 ( RD-0901 ) is a high noble alloy under Identalloy and ADA classification system for Dental alloy. It is designed for porcelain application ( PFM-alloy ) and compatible with most of the porcelain in the market. Jelfine-52 exhibits similar physical and thermal properties like Jelenko's "Olympia" and it provides quality restorations with rich platinum color. It polishes to a high luster. This high noble alloy is copper and silver free. Jelfine-52 provides accurate margins and it is perfect for single, 3 to 4 crowns and long span bridges.
Image /page/2/Picture/5 description: The image shows a handwritten signature and date. The signature appears to be in cursive script, with some flourishes and overlapping strokes. The date is written as 7/10/98, indicating July 10, 1998. The writing is in black ink on a white background.
(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 5 ntal, Infection Control, and General Hospital Devices (k) Number Prescription Usc OR Over-The-Counter Use
§ 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.