GOLD CORE 35

K023501 · Pentron Laboratory Technologies · EJT · Dec 18, 2002 · Dental

Device Facts

• Record ID: K023501
• Device Name: GOLD CORE 35
• Applicant: Pentron Laboratory Technologies
• Product Code: EJT · Dental
• Decision Date: Dec 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Gold Core 35 is a noble, yellow alloy to be used for inlays, onlays, single crown, bridges,. implant superstructures and substrate for low fusing, high expansion porcelains and composites. .

Device Story

Gold Core 35 is a noble, yellow dental alloy. It serves as a restorative material for inlays, onlays, crowns, bridges, and implant superstructures, or as a substrate for porcelain and composite layering. Used by dental laboratory technicians and clinicians to fabricate dental prosthetics. The alloy provides structural support and a base for aesthetic dental materials. It is intended for prescription use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Noble, yellow dental alloy. Formulated for compatibility with low fusing, high expansion porcelains and composites. Class II medical device (21 CFR 872.3060).

Indications for Use

Indicated for use in dental restorations including inlays, onlays, single crowns, bridges, implant superstructures, and as a substrate for low fusing, high expansion porcelains and 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

• Gold Core 55 (K993173)

Submission Summary (Full Text)

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## 21.0 510(K) SUMMARY

Gold Core 35 is a noble, yellow alloy to be used for inlays, onlays, single crowns, bridges, implant superstructures and substrates for low fusing, high expansion porcelains and composites. Gold Core 35 is substantially equivalent to Gold Core 55, K993173 with the exception of a minor few elements. However, the addition of these elements does not affect safety and effectiveness.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Greg Jimmie Management Representative Pentron Laboratory Technologies, LLC 53 North Plains Industrial Road Wallingford, Connecticut 06492-0724

Re: K023501

Trade/Device Name: Gold Core 35 Regulation Number: 21 CFR 872.3060 Regulation Name: Gold-based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: October 16, 2002 Received: October 18, 2002

Dear Mr. Jimmie:

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 - Mr. Greg Jimmie

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 (QS) 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). 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/cdrl/dsma/dsmamain.html

Sincerely yours,

Paluxai Cucenttyfhor

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

Enclosure

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# 5.0 INDICATION FOR USE STATEMENT

# 023501 510(k) NUMBER (IF KNOWN):

### Gold Core 35 - - -DEVICE NAME:

# INDICATION FOR USE;

Gold Core 35 is a noble, yellow alloy to be used for inlays, onlays, single crown, bridges,. implant superstructures and substrate for low fusing, high expansion porcelains and composites. .

Sweta Rurua

Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number:

# (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 1-2-96) 5.0

Pentron Laboratory Technologies, LLC. 510K Submission - Gold Core 35