PORTA AURIUM, MODEL 2067

K012827 · Wieland Edelmetalle GmbH & Co. · EJT · Nov 1, 2001 · Dental

Device Facts

• Record ID: K012827
• Device Name: PORTA AURIUM, MODEL 2067
• Applicant: Wieland Edelmetalle GmbH & Co.
• Product Code: EJT · Dental
• Decision Date: Nov 1, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2

Intended Use

Porta Aurium is a universal gold-based dental alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Inlays/ Onlays . Partial crowns ● . Crowns . Short span bridges . Long span bridges . Removable partials . and can be used for . Telescopic and milling work . Porta Aurium can be veneered with low-fusing dental ceramics with high expansion as well as with dental-composites.

Device Story

Porta Aurium is an extra-hard, gold-based dental alloy (80.5% noble metal content) used by dental technicians in laboratory settings to fabricate dental restorations. The alloy is cast or milled to create inlays, onlays, crowns, bridges, and removable partials. It is copper-free, facilitating telescopic and milling applications. The material is compatible with low-fusing dental ceramics and composites, with its golden color providing an aesthetic base. The final restoration is placed by a dentist to restore patient dental function and aesthetics. The device benefits patients by providing a corrosion-resistant, biocompatible, and durable restorative material.

Clinical Evidence

Bench testing only. The device complies with international standard ISO 9693 for dental alloys.

Technological Characteristics

Extra-hard gold-based dental alloy; 80.5% noble metal content; copper-free. Form factor: dental casting/milling alloy. Complies with ISO 9693. Suitable for veneering with low-fusing dental ceramics and composites.

Indications for Use

Indicated for use by dental technicians to fabricate dental appliances including inlays, onlays, partial crowns, crowns, short/long span bridges, removable partials, and telescopic/milling work for patients requiring 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

• Pontor 4 CF (K911541)

Submission Summary (Full Text)

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K012827

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## NOV 0 1 2001 Premarket Notification 510(k)

Porta Aurium

## 5. 510 (k) Summary

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

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

2001-07-21 Date of Summary:

Porta Aurium Trade name:

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

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

Legally marketed Pontor 4 CF equivalent device: 510(k) number: K911541

## Device description

Porta Aurium is an extra-hard universal alloy with high contents of noble metals (80,5%), intended for dental technicians to fabricate dental restorations.

It has an indication which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics and to removable partials. It is free of copper and therefore suitable for telescopic and milling work.

Porta Aurium is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.

Porta Aurium can be veneered with low-fusing dental ceramics with high expansion and with dental composites, in which the golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 1 7001

Dr. Gerhard Polzer Director of Regulatory Affairs Weiland Edelmetalle GmbH & Company Schwenninger Strabe 13 D-75179 Pforzheim, GERMANY

Re: K012827

Trade/Device Name: Porta Aurium, Model 2067 Regulation Number: 872.3060 Regulation Name:Alloy, Gold Based, For Clinical Use Regulatory Class: II Product Code: EJT Dated: October 18, 2001 Received: October 22, 2001

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.

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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of the Act or any Federal statutes and regulations administered by other Federal agencies. Vou 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.

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

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NOV 01 2001

K012827

Premarket Notification 510(k)

Porta Aurium

## 4. Statement of indication for use

Porta Aurium is a universal gold-based dental alloy that can be used by dental technicians to fabricate dental appliances for patients.

It is intended for manufacturing

- Inlays/ Onlays .
- Partial crowns ●
- . Crowns
- Short span bridges .
- Long span bridges .
- Removable partials .

and can be used for

- Telescopic and milling work .
Porta Aurium can be veneered with low-fusing dental ceramics with high expansion as well as with dental-composites.

Susan Runne

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