← Product Code [EJT](/productcode/EJT) · K973372

# AUROFILM 2000 (K973372)

_Metalor Dental USA Corp. · EJT · Nov 26, 1997 · Dental · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K973372

## Device Facts

- **Applicant:** Metalor Dental USA Corp.
- **Product Code:** [EJT](/productcode/EJT.md)
- **Decision Date:** Nov 26, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3060
- **Device Class:** Class 2
- **Review Panel:** Dental

## Indications for Use

For Enhancement of Porcelain Bond and Color in Porcelain Fused-to-Metal Dental Crowns and Bridges.

## Device Story

Aurofilm 2000 is a dental material used to improve the bonding and color characteristics of porcelain fused-to-metal (PFM) dental crowns and bridges. It is applied by dental professionals in a clinical or laboratory setting during the fabrication or preparation of dental restorations. The device functions as an interface or coating agent to ensure optimal adhesion between the metal substructure and the porcelain veneer, while also assisting in achieving the desired aesthetic color match. By enhancing the bond, it helps prevent restoration failure; by improving color, it ensures the final prosthesis matches the patient's natural dentition. The healthcare provider applies the material as part of the standard crown and bridge restoration workflow.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Dental material for porcelain-to-metal bonding and color enhancement. Formulated for use in PFM crown and bridge applications. No specific materials, energy sources, or software components described.

## 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.

## Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 6 1997

Mr. Kenneth A. Putney rir. Remicen in Facily
Vice President, General Manager Official Correspondent Metalor Dental USA Corporation 255 John L. Dietsch Boulevard North Attleborough, Massachusetts 02761

K973372 Re: Aurofilm 2000 Trade Name: Regulatory Class: II Product Code: EJT September 2, 1997 Dated: Received: September 8, 1997

Dear Mr. Putney:

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, Druq, 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 Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 obligation you might have under sections 531

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Page 2 - Mr. Putney

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.ffaa.gov/cdrh/dsmamain.html".

Sincerely yours,

O. Alltrust

Timothy A. Ulatowski Directbr 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):_____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

## For Enhancement of Porcelain Bond and Color in PorcelainFor Carol Transdate Motal Dental Crowns and Bridges. ancement of Porcelain Bond and Containc Commission of Crowns and Bridges.
Fused-to-Metal Dental Crowns and Bridges.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off)                                                 |         |
|---------------------------------------------------------------------|---------|
| Division of Dental, Infection Control, and General Hospital Devices |         |
| 510(k) Number                                                       | K973372 |

| Prescription use (Per 21 CFR 801.109) | <div style="text-align:center;">OR</div> | Over-The-Counter Use (Optional Format 1-2-96) |
|---------------------------------------|------------------------------------------|-----------------------------------------------|
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**Source:** [https://fda-staging.innolitics.com/device/K973372](https://fda-staging.innolitics.com/device/K973372)

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