GOLD CORE 55

K993173 · Jeneric/Pentron, Inc. · EJT · Oct 26, 1999 · Dental

Device Facts

• Record ID: K993173
• Device Name: GOLD CORE 55
• Applicant: Jeneric/Pentron, Inc.
• Product Code: EJT · Dental
• Decision Date: Oct 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Gold Core 55 is a Type IV, high noble, yellow alloy to be used for inlays, onlays, single crown briges, implant superstructures and substrate for low wear products and other medium expansion lower fusing porcelains and indirect restorative composites. Particularly, OPC Low Wear, K982377, Jeneric/Pentron, which is a low temperature ceramic.

Device Story

Gold Core 55 is a high noble, yellow, micro-fine gold-based dental alloy. It serves as a restorative material for inlays, onlays, single crowns, bridges, and implant superstructures. It functions as a substrate for medium expansion, lower-fusing porcelains and indirect restorative composites, specifically compatible with OPC Low Wear ceramics. The device is used in dental clinical settings by dental professionals to fabricate dental prosthetics. It provides a durable, biocompatible foundation for dental restorations, benefiting patients by restoring tooth structure and function.

Clinical Evidence

Bench testing only.

Technological Characteristics

High noble, yellow, micro-fine gold-based alloy. Composition: 55% Au, 29% Ag, 10% Pd, with trace amounts of In, Sn, Zn, Ir. Type IV alloy classification.

Indications for Use

Indicated for dental patients requiring inlays, onlays, single crowns, bridges, or implant superstructures. Used as a substrate for low-wear products, medium expansion lower-fusing porcelains, and indirect restorative composites.

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.

Predicate Devices

• KB58-KF (K922958)

Reference Devices

• OPC Low Wear (K982377)

Submission Summary (Full Text)

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OCT 26 1999

## 510(K)SUMMARY K993173

## Jeneric/Pentron, Inc. Submitted by: 53 North Plains Industrial Road Wallingford, Connecticut 06492

Annmarie Tenero Contact Person: [phone] X 619

October 20, 1999 Revised Summary:

Gold Core 55 Device Name:

Gold Core 55 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for inlays, onlays, Cord Corc 35 is a Fright Noberstructures, substrate for medium expansion lower fusing single crowns, brugos, imposites. Particularly to be used with OPC Low Wear, porcelains me menter resear porcelain. We believe that Gold Core 55 is substantially equivalent, to KB58-KF, K922958, Jeneric/Pentron, Inc., which is currently in commercial distribution in the U.S. A. The chemical composition of Gold Core 55 is as follows:

Au - 55% Ag - 29% Pd - 10% Balance Amounts of: In, Sn, Zn, Ir

Jeneric/Pentron, Inc. 510K Submission - Gold Core 55

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 26 1999

Ms. Annmarie Tenero Jeneric®/Pentron® Incorporated 53 North Plains Industrial Road P.O. Box 724 Wallingford, CT 06492-0724

- K993173 Re : Gold Core 55 Trade Name: Requlatory Class: II Product Code: EJT September 17, 1999 Dated: Received: September 22, 1999
Dear Ms. Tenero:

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 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 Failure to comply with the GMP verify such assumptions. requlation 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

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Page 2 - Ms. Tenero

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.

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 qeneral 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.fdangov/cdrh/dsmamain.html" a

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

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510(k) NUMBER (IF KNOWN): K993173

DEVICE NAME: GOLD CORE 55

INDICATIONS FOR USE:Gold Core 55 is a Type IV, high noble, yellow alloy to be used for inlays, onlays, single crown briges, implant superstructures and substrate for low wear products and other medium expansion lower fusing porcelains and indirect restorative composites. Particularly, OPC Low Wear, K982377, Jeneric/Pentron, which is a low temperature ceramic.

(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)

OR

Over-The-Counter-Use (Optional Format 1-2-

Susan Yunn

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number .