← Product Code [EJT](/productcode/EJT) · K021741

# CRITERTION, MODEL #1067511 (K021741)

_Sterngold · EJT · Jun 26, 2002 · Dental · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K021741

## Device Facts

- **Applicant:** Sterngold
- **Product Code:** [EJT](/productcode/EJT.md)
- **Decision Date:** Jun 26, 2002
- **Decision:** SESE
- **Submission Type:** Abbreviated
- **Regulation:** 21 CFR 872.3060
- **Device Class:** Class 2
- **Review Panel:** Dental

## Indications for Use

Precious Alloy for use in dental restorations where porcelain application is indicated.

## Device Story

Criterion is a white porcelain dental alloy used by dental professionals for the fabrication of ceramic dental restorations. The alloy serves as a substrate for porcelain application. It is intended for prescription use in a clinical dental setting to restore tooth structure or function.

## Clinical Evidence

Bench testing only. No clinical data provided.

## Technological Characteristics

White porcelain dental alloy. Class II device (Product Code EJT).

## Regulatory 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

- Jel 96 ([K944679](/device/K944679.md))
- Argedent 74 ([K892335](/device/K892335.md))
- Degudent GS ([K905387](/device/K905387.md))
- V-Supra Plus ([K993508](/device/K993508.md))

## Submission Summary (Full Text)

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Criterion

Special 510(k) Premarket Notification: Abbreviated 510(k)

Ka21741

# 510(k) Summary

Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Sterngold is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." Sterngold chooses to submit a summary of the safety and effectiveness information. The summary is as follows:

| Trade Name:          | Criterion                                                                                                       |
|----------------------|-----------------------------------------------------------------------------------------------------------------|
| 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. |

#### Predicate Devices:

| Alloy Name   | 510(k)     | Manufactured By |
|--------------|------------|-----------------|
| Jel 96       | (k) 944679 | Jelenko         |
| Argedent 74  | (k) 892335 | Argen           |
| Degudent GS  | (k) 905387 | Degussa         |
| V-Supra Plus | (k) 993508 | Metalor         |

#### Product Description:

Criterion is a White Porcelain Dental Alloy.

#### Indications for Use:

Precious alloy for use in Ceramic dental restorations.

#### Safety and Performance:

This submission is a Special 510(k): Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Sterngold has provided information to demonstrate conformity with FDA's guidance document entitled Guidance Document for the Preparation of Premarket Notifications [510](k) s] for Dental Alloys).

#### Conclusion:

Based on the indications for use, technological characteristics, and comparison to predicate devices, Criterion has been shown to be safe and effective for its intended use.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2002

Ms. Maria Rao Quality Manager Sterngold 23 Frank Mossberg Drive Attleboro, Massachusetts 02703-0967

Re: K021741

Trade/Device Name: Criterion Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: May 20, 2002 Received: May 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 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.

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

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### Page 2 - Ms. Maria Rao

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 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 (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/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

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Page 1 of

510(k) Number (if known): *K021741*

Device Name: __ Criterion

Indications for Use:

Precious Alloy for use in dental restorations where porcelain application is indicated.

## (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_

Susan Runne

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

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**Source:** [https://fda-staging.innolitics.com/device/K021741](https://fda-staging.innolitics.com/device/K021741)

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