(43 days)
It is a gold / Platinum porcelain-to-metal alloy with high strength and hardness. It is suitable for longspans and bridges. It is a high noble alloy and it enhances the esthetic qualities of the finished porcelain restoration. It is compatible with a wide range of porcelains.
It is a gold / Platinum porcelain-to-metal alloy with high strength and hardness.
This document is a 510(k) clearance letter from the FDA for a dental alloy named "Jel-71 PdF." It states that the device is substantially equivalent to legally marketed predicate devices. However, this type of document does not contain details about specific acceptance criteria, study designs, or performance metrics in the way you are requesting for a device evaluation.
510(k) clearances are primarily based on demonstrating substantial equivalence to a predicate device, not necessarily on new clinical performance data or effectiveness studies that quantify improvement with AI, for instance. The focus is often on comparing material properties, biocompatibility, and intended use against existing devices.
Therefore, I cannot provide the detailed information you requested about acceptance criteria and a study proving device performance because this information is not present in the provided FDA 510(k) clearance letter or its accompanying Indications for Use statement.
The document only provides:
- Device Name: Jel-71 PdF
- Product Code: EJT
- Regulatory Class: II
- Indications For Use: "It is a gold / Platinum porcelain-to-metal alloy with high strength and hardness. It is suitable for long-spans and bridges. It is a high noble alloy and it enhances the esthetic qualities of the finished porcelain restoration. It is compatible with a wide range of porcelains."
To get the kind of detailed information you're asking for (acceptance criteria, specific study design, sample sizes, ground truth establishment, AI assistance, etc.), you would typically need to refer to specific premarket approval (PMA) applications, detailed study reports, or scientific publications related to the device, which are not included in this 510(k) response.
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting three abstract shapes, which are often interpreted as representing the three levels of healthcare services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 20 1997
Mr. Tridib Dasqupta Director R&D and Q.C J.F. Jelenko and Company 99 Business Park Drive Armonk, New York 10504 USA
K971292 Re : Jel-71 PdF Trade Name: Requlatory Class: II Product Code: EJT Dated: April 3, 1997 Received: April 7, 1997
Dear Mr. Dasqupta:
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, Druq, 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. ਮੁ 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 Reqister. 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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Page 2 - Mr. Dasqupta
This letter will allow you to begin marketing your device as described in vour 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, "Misbrandinq 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. 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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DENTAL MALTH PRODUCTS ISO 9001 REGISTERED
99 RUSINESS PARK DRIVE, ARMONK, NEW YORK 10504 USA
(800) 431-1785
301 480 3002 => JELENKO_; #3 12- 9-96; 9:40; FDA/ODE/DDIGD MON 09:45 FAX 301 480 3002 12/09/06
2003
Page 1 of 1
510(k) Number (if known): not available
Device Name: Jel-11PdF
Indications For Use:
It is a gold / Platinum porcelain-to-metal alloy with high strength and hardness. It is suitable for longspans and bridges. It is a high noble alloy and it enhances the esthetic qualities of the finished porcelain restoration. It is compatible with a wide range of porcelains.
Richa Dasgupta
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
UNNY (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices પ્ર /
510(k) Number
VES Prescription Use (Per 21 CFR 801. 109) OR
Over-The-Counter Use NO
§ 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.