JEL-71 PDF

K971292 · J.F. Jelenko & Co., Inc. · EJT · May 20, 1997 · Dental

Device Facts

• Record ID: K971292
• Device Name: JEL-71 PDF
• Applicant: J.F. Jelenko & Co., Inc.
• Product Code: EJT · Dental
• Decision Date: May 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Jel-71PdF is a high noble gold/platinum alloy used in dentistry for porcelain-to-metal restorations. Designed for high strength and hardness, it provides structural support for longspans and bridges while enhancing the esthetic quality of finished restorations. The alloy is compatible with a wide range of dental porcelains. It is intended for prescription use by dental professionals in a clinical or laboratory setting to fabricate dental prosthetics.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

High noble gold/platinum alloy; metallic composition; high strength and hardness; compatible with dental porcelains; intended for casting/fabrication of dental restorations.

Indications for Use

Indicated for use as a high noble gold/platinum porcelain-to-metal alloy for dental restorations, specifically suitable for longspans and bridges.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
MAY 20 1997
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

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

Re: K971292
Trade Name: Jel-71 PdF
Regulatory 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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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.

{1}

Page 2 - Mr. Dasgupta

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

{2}

DENTAL HEALTH PRODUCTS
ISO 9001 REGISTERED
99 BUSINESS PARK DRIVE, ARMONK, NEW YORK 10504 USA
[phone]
12 9-96; 9:40; 301 480 3002 => JELENKO; #3
12/09/96 MON 09:45 FAX [phone] FDA/ODE/DDIGD
003
Page 1 of 1
510(k) Number (if known): not available K971292
Device Name: Jel-71PdF
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.
(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 Dental, Infection Control, and General Hospital Devices
510(k) Number K971292
Prescription Use YES
(Per 21 CFR 801.109)
OR
Over-The-Counter Use NO
(Optional Format 1-2-96)