AUROPAL 60

K021926 · Wieland Dental + Technik GmbH & Co. KG · EJT · Jul 25, 2002 · Dental

Device Facts

• Record ID: K021926
• Device Name: AUROPAL 60
• Applicant: Wieland Dental + Technik GmbH & Co. KG
• Product Code: EJT · Dental
• Decision Date: Jul 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2

Intended Use

Auropal 60 is a gold-silver casting alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing • Inlays and Onlays, and • Crowns

Device Story

Auropal 60 is a gold-silver dental casting alloy containing 63.7% noble metals. It is used by dental technicians in a laboratory setting to fabricate dental restorations, specifically inlays, onlays, and crowns. The alloy is melted and cast to form the desired dental appliance. It provides a corrosion-resistant material for restorative dentistry, benefiting patients by providing durable dental prosthetics.

Clinical Evidence

Bench testing only. The device complies with ISO 8891 requirements for mechanical properties and corrosion resistance.

Technological Characteristics

Gold-silver casting alloy; 63.7% noble metal content. Classified as a Type 3 casting alloy per ISO 8891. High corrosion resistance. Material properties meet international standard ISO 8891 and European directive 93/42/ECC.

Indications for Use

Indicated for use by dental technicians to fabricate dental appliances, specifically inlays, onlays, and crowns for patients requiring dental restoration.

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

• Densilav

Submission Summary (Full Text)

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JUL 2 5 2002

K091926

## Premarket Notification 510(k)

Auropal 60

### 5. 510 (k) Summary

| Submitter of 510(k): | Wieland Dental + Technik GmbH & Co. KG |
|----------------------|----------------------------------------|
| | Schwenninger Str. 13 |
| | D-75179 Pforzheim |
| | Germany |
| | Phone: [phone] |

| Contact person: | Dr. Gerhard Polzer |
|-----------------|----------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| e-mail: | [e-mail] |

Date of Summary: 2002-04-12

Trade name: Auropal 60

Classification name: Product code: C.D.R section: Classification:

Alloy, gold based, for clinical use EJT 872.3060 Class II

Legally marketed equivalent device: Densilav Manufacturer: Degussa AG

#### Device description

Auropal 60 is a dental gold-silver casting alloy (63,7% noble metals), intended for dental technicians to fabricate dental restorations.

On the basis of it's mechanical properties, Auropal 60 is a Type 3 casting alloy, according to ISO 8891.

The indications of Auropal 60 comprise inlays/onlays and crowns.

Auropal 60 is highly corrosion resistant and it fully complies with the requirement of the international standard ISO 8891 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the left.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# (JUL 2 5 2002

Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Dental + Technik GmbH & Co. KG Schwenninger Straße 13 D-75179 Pforzheim GERMANY

Re: K021926

Trade/Device Name: Auropal 60 Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: May 14, 2002 Received: June 12, 2002

Dear Dr. Polzer:

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 - Dr. Gerhard Polzer

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic 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" (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

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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Page 1 of 1

510(k) Number (if known): K021926

Auropal 60

Device Name:__________________________________________________________________________________________________________________________________________________________________

、

Indications For Use:

Auropal 60 is a gold-silver casting alloy that can be used by dental technicians to fabricate dental appliances for patients.

It is intended for manufacturing

• Inlays and Onlays, and

• Crowns

(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)

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