(43 days)
It is a gold / platinum porcelain-to-metal alloy with high strength and hardness with superfine grain structure. It is suitable for longspans and bridges. It is a high noble alloy and the high goldcontent makes it compatible with most porcelains in the market.Jelbond-PdF blend well with tissue and enhances the esthetic qualities of the finished restoration.
It is a gold / platinum porcelain-to-metal alloy with high strength and hardness with superfine grain structure.
This document is a 510(k) premarket notification approval letter for the device "Jelbond-PdF". It does not contain any information regarding acceptance criteria, device performance, or study details such as sample sizes, ground truth establishment, or expert qualifications.
The letter confirms that the FDA has reviewed the submission and found the device to be substantially equivalent to a legally marketed predicate device. This substantial equivalence determination allows the manufacturer to market the device.
Therefore, I cannot provide the requested information based on the input text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1997
Mr. Tridib Dasgupta Director R&D and Q.C J.F. Jelenko and Company 99 Business Park Drive Armonk, New York 10504 USA
Re : K971574 Trade Name: Jelbond-PdF Requlatory Class: II Product Code: EJT Dated: April 3, 1997 Received: April 7, 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, qood 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 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.
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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,
Timothy A. Ulatowski
av A. Ulatowsk Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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99 BUSINESS PARK DRIVE, ARMONK, NEW YORK 10504 USA
| 12- 9-96; | 9:40; | 301 480 3002 => JELENKO_; #3 | (800) 431-1785 |
|---|---|---|---|
| 2/09/96 MON 09:45 FAX 301 480 3002 | FDA/ODE/DDIGD | 003 |
Page 1 of 1
| 510(k) Number (if known): | not available |
|---|---|
| Device Name: | Jelbond-PdF |
Indications For Use:
It is a gold / platinum porcelain-to-metal alloy with high strength and hardness with superfine grain structure. It is suitable for longspans and bridges. It is a high noble alloy and the high goldcontent makes it compatible with most porcelains in the market.Jelbond-PdF blend well with tissue and enhances the esthetic qualities of the finished restoration.
Rich Daggett...
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susar Kunnes
(Divison Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices 510(k) Number
Prescription Use yES (Per 21 CFR 801.109) OR
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.