(41 days)
Prospector Plus is a noble alloy under the Identalloy and ADA classification system for Dental Alloy. It is designed for Type-III hard Crown and Bridge alloy. Prospector Plus provides quality restorations. It is low gold containing alloy vet having rich brilliant gold color and it polishes to a higher luster. This noble alloy, free from Copper, makes it excellent tarnish resistant. Prospector Plus provides extremely accurate margins. It is perfect for Single Crown, Veneer Crowns, 3 to 4 crowns and short span bridges.
Prospector Plus is a noble alloy under the Identalloy and ADA classification system for Dental Alloy. It is designed for Type-III hard Crown and Bridge alloy. Prospector Plus provides quality restorations. It is low gold containing alloy vet having rich brilliant gold color and it polishes to a higher luster. This noble alloy, free from Copper, makes it excellent tarnish resistant. Prospector Plus provides extremely accurate margins.
The provided document is a 510(k) premarket notification letter from the FDA to J.F. Jelenko & Company, Incorporated, regarding a dental alloy named "Prospector Plus." This document confirms the device's substantial equivalence to a predicate device but does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The letter is a regulatory approval, and while it indicates the device's intended use and classification, it does not delve into the specific performance metrics or clinical study results that would typically be detailed in a submission proving performance against acceptance criteria.
Therefore, I cannot provide answers to the requested information based on the given text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three intertwined strands representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tridib Dasgupta ·Director Research & Development J.F. Jelenko & Company, Incorporated 99 Business Park Drive Armonk, New York 10504
NUN 2 4 1997
Re : K973881 Prospector Plus (Code Name : RD-0508) Trade Name: Requlatory Class: II EJT Product Code: October 8, 1997 Dated: Received: October 14, 1997
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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation 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
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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 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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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. Allatrot
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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99 BUSINESS PARK DRIVE, ARMONK, NEW YORK U.S.A. 10504 • (914) 273-8600
Page 1 of 1
F A X: ( 9 1 4 ) 2 7 3 - 9 3 7 9
510(k) Number (if known): K97388/
Device Name: PROSPECTOR PLUS ( Code Name : RD-0508 )
J. F. JELENKO & CO. -
Indications For Use:
DENTAL HEALTH PRODUCTS
Prospector Plus is a noble alloy under the Identalloy and ADA classification system for Dental Alloy. It is designed for Type-III hard Crown and Bridge alloy. Prospector Plus provides quality restorations. It is low gold containing alloy vet having rich brilliant gold color and it polishes to a higher luster. This noble alloy, free from Copper, makes it excellent tarnish resistant. Prospector Plus provides extremely accurate margins. It is perfect for Single Crown, Veneer Crowns, 3 to 4 crowns and short span bridges.
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Do 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) Yes
Over-The-Counter Use NO
(Optional Format 1-2-96)
§ 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.