GOLD CORE PLUS

K023499 · Pentron Laboratory Technologies · EJH · Jan 13, 2003 · Dental

Device Facts

• Record ID: K023499
• Device Name: GOLD CORE PLUS
• Applicant: Pentron Laboratory Technologies
• Product Code: EJH · Dental
• Decision Date: Jan 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3710
• Device Class: Class 2

Intended Use

Gold Core Plus is indicated for use as crowns, bridges, substrate for accepting high expansion porcelains.

Device Story

Gold Core Plus is a dental alloy used by dental laboratories as a substrate for crowns and bridges and for bonding high expansion porcelains. The device is a metallic material processed by dental technicians to form dental restorations. It functions as a structural base for prosthetic dental work. The clinical benefit is the provision of a durable, corrosion-resistant framework for dental restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Base metal alloy for dental restorations. Contains Molybdenum for improved corrosion resistance. Class II device (21 CFR 872.3710, Product Code EJH).

Indications for Use

Indicated for use as crowns, bridges, and substrate for accepting high expansion porcelains in dental patients.

Regulatory Classification

Identification

A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is 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

• Jewel Cast II (K003039)

Submission Summary (Full Text)

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K023499

### 21.0 510(K) SUMMARY

JAN 1 3 2003

Gold Core Plus is indicated for use as crowns, bridges, substrate for accepting high expansion porcelains. Gold Core Plus is substantially equivalent to Pentron Laboratory Technologies, LLC., Jewel Cast II, K003039. Gold Core Plus contains the same elements as Jewel Cast II with the exception of one element. However, the addition of this element does not affect safety or effectiveness because it has improved the corrosion resistance of the alloy. Also, Molybdenum has been used successfully in Ni-Cr alloys for over 30 years.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2003

Ms. Annmarie Tenero Paralegal Pentron Laboratory Technologies, LLC 53 North Plains Industrial Road P.O. Box 724 Wallingford, Connecticut 06492-0724

Re: K023499 Trade/Device Name: Gold Core Plus Regulation Number: 21 CFR 872.3710 Regulation Name: Base Metal Alloy Regulatory Class: II Product Code: EJH Dated: October 16, 2002 Received: October 18, 2002

Dear Ms. Tenero:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Annmarie Tenero

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

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# 5.0 INDICATION FOR USE STATEMENT

### 11023499 510(k) NUMBER (IF KNOWN):

#### Gold Core Plus DEVICE NAME:

INDICATION FOR USE:

Gold Core Plus is indicated for use as crowns, bridges, substrate for accepting high expansion porcelains.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 2 (Per 21 CFR 801.109) OR

Over -The-Counter-Use (Optional Format 1-2-96)

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Susan Rummer
Division Sign-Off

(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices

510(k) Number ._

Pentron Laboratory Technologies, LLC. 510K Submission – Gold Core Plus