STERNGOLD 1, MODEL 1127781

K022252 · Sterngold · EJS · Sep 19, 2002 · Dental

Device Facts

• Record ID: K022252
• Device Name: STERNGOLD 1, MODEL 1127781
• Applicant: Sterngold
• Product Code: EJS · Dental
• Decision Date: Sep 19, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Precious Alloy for use in Crown and Bridge Dental Restorations.

Device Story

Sterngold 1 is a yellow crown and bridge dental alloy. It is used by dental professionals to fabricate dental restorations. The device serves as a restorative material for crown and bridge applications, providing a precious metal solution for dental health.

Clinical Evidence

Bench testing only.

Technological Characteristics

Yellow crown and bridge dental alloy. Class II device (Product Code EJS).

Indications for Use

Indicated for use in crown and bridge dental restorations for patients requiring such dental prosthetics.

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

• Harmony Medium (k905330)
• Monogram II (k895064)

Submission Summary (Full Text)

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Stern old 5100k · Premarket Notification - Abbreviated SEP 1 9 2002

Kozzz52

510(k) Summary

Purs any to 12(i)(3)(A) of the Food, Drug and Cosmetic Act, Sterngold is required to submit with this Premarket Noti ication either an "...adequate summary of any information respecting safety and effectiveness or state that info mation will be made available upon request of any person." Sterngold chooses to submit a summary of the safe y and e fectiveness information. The summary is as follows:

| Trade Name: | Sterngold 1 |
|----------------------|----------------------------------------------------------------------------------------------------------------|
| Sponsor: | Sterngold<br>23 Frank Mossberg Drive<br>P.O. Box 2967<br>Attleboro, MA 02703-0967<br>Registration #2921595 |
| Device Generic Name: | Dental Alloy |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II |

Pre licate Devices:

| Alloy Name | 510(k) | Manufactured By |
|----------------|------------|-----------------|
| Harmony Medium | (k) 905330 | Ivoclar |
| Monogram II | (k) 895064 | Leach & Dillon |

## Product Description:

Ste ngold 1 is a Yellow Crown and Bridge Alloy.

## Indication: for Use:

Pre ious al oy for use in Crown and Bridge dental restorations.

## Sat ty and Performance:

This submission is a Special 510(k): Abbreviated 510(k) as described in FDA's guidance document entitled "The Ne v 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket No ificatio is." In support of this 510(k), Sterngold has provided information to demonstrate conformity with FD 1's guilance document entitled Guidance Document for the Preparation of Premarket Notifications [510(k) 's] for Dental Alloys).

## Conclusion:

Ba ed on the indications for use, technological characteristics, and comparison to predicate devices, Sterngold 1 has been show to be safe and effective for its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 1 9 2002

Ms. Maria Rao Quality and Regulatory Affairs Manager STERNGOLD 23 Frank Mossberg Drive Attleboro, Massachusetts 02703-0967

Re: K022252

Trade/Device Name: Sterngold 1 Regulation Number: 872.3060 Regulation Name: Gold-based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJS Dated: June 28, 2002 Received: July 28, 2002

Dear Ms. Rao:

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 vour 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.

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.

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Page 2 - Ms. Rao

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4613. 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Patricia Cunliffe

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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Sterngold 510(k) Premarket Notification - Abbreviated June 28, 2002 Sterngold 1

Kozz252

Page of

510(k) Number (if known):

Device Name: Sterngold 1

Indications for Use:

Precious Alloy for use in Crown and Bridge Dental Restorations.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use צ (Per 21 CFR 801.109)

OR

Over-the -Counter Use

Susan Ruma

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

510(k) Number: k003252