AURECAST 92

K972943 · Aurex Precious Metal Industries (Pty)Ltd · EJT · Sep 16, 1997 · Dental

Device Facts

• Record ID: K972943
• Device Name: AURECAST 92
• Applicant: Aurex Precious Metal Industries (Pty)Ltd
• Product Code: EJT · Dental
• Decision Date: Sep 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Dental casting alloy for making restoration.

Device Story

Aurecast 92 is a high gold casting alloy used by dental professionals for the fabrication of Type I dental restorations. The device is a metallic material intended for casting procedures in a dental laboratory setting. It serves as a restorative material to replace missing tooth structure or restore dental function. The healthcare provider uses the alloy to cast custom dental prosthetics, which are then fitted to the patient to restore oral health and function.

Clinical Evidence

Bench testing only. Physical and mechanical properties were evaluated and compared to the predicate device using ANSI/ADA 5 and ISO 1562 standards.

Technological Characteristics

High gold casting alloy. Composition: 91.7% Au, 6% Ag, 2.3% Cu. Physical properties: Melting range 1010-1030°C, Vickers hardness 70-100, yield strength 220-360 MPa, elongation 22-45%, density 18.2 g/cm3. Tested per ANSI/ADA 5 and ISO 1562.

Indications for Use

Indicated for use as a dental casting alloy for the fabrication of Type I dental restorations.

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

• Argencco Bio 10 (K972943)

Submission Summary (Full Text)

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P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : [phone] Telefax : [phone]

K972943

## 510 (k) Summary

Trade name: AURECAST 92 Common name: Dental casting alloy Gold based alloys and precious metal alloys for clinical use Classification name: EIT. Class ification number:

Legally marketed device: Argen Argencco Bio 10 Description of the device: High gold casting alloy Intended use of the device: Type I restorations

## Summary of the technological characteristics

Test methods applied: as in ANSI/ADA 5 and ISO 1562

Comparison of composition:

| ALLOY | | COMPOSITION (weight%) | | |
|-------|--------------|-----------------------|----|-----|
| | Name | Au | Ag | Cu |
| Legal | ArgencoBio10 | 91.7 | 6 | 2.3 |
| New | Aurecast 92 | 91.7 | 6 | 2.3 |

x is less than 1 %

Comparison of physical and mechanical properties

| ALLOY | | Melting point<br>range (oC) | | Hardness<br>(Vickers<br>5/30) | Yield<br>strength<br>(MPa) | | Elongation<br>(%) | | Density<br>(g/cm3) | |
|-------|---------------|-----------------------------|------|-------------------------------|----------------------------|------|-------------------|------|--------------------|------|
| Name | solid. | liquid | soft | hard | soft | hard | soft | hard | | |
| Legal | Argenco Bio10 | 1010 | 1030 | 70 | | 220 | | 45 | | 18.2 |
| New | Aurecast 92 | 1010 | 1030 | 70 | 75 | 100 | 360 | 45 | 22 | 18.2 |

## Discussion

The two alloys are identical.

TÜV

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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 an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 1997

Mr. Jerome D. Davis Managing Director Aurex Precious Metal Industries (PTY) Ltd. P.O. Box 509 Edenvale 1610 Republic of South Africa

Re: K972943 Trade Name: Aurecast 92 Requlatory Class: II Product Code: EJT Dated: June 13, 1997 Received: June 20, 1997

Dear Mr. Davis:

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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. ਬੋ 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 requlation (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 requlatory 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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Paqe 2 - Mr. Davis

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 diaqnostic devices), 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" (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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patricia Cocciante // foc

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

Enclosure

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510(k) Number (if known): _

AURECAST 92 Device Name:

Indications For Use:

Dental casting alloy for making restoration.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rimmer

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

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)