PORTA SMK 82, MODEL 2032

K012828 · Wieland Edelmetalle GmbH & Co. · EJS · Nov 1, 2001 · Dental

Device Facts

• Record ID: K012828
• Device Name: PORTA SMK 82, MODEL 2032
• Applicant: Wieland Edelmetalle GmbH & Co.
• Product Code: EJS · Dental
• Decision Date: Nov 1, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2

Intended Use

Porta SMK 82 is a gold-palladium ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Partial crowns . - Crowns . - Short span bridges . - Long span bridges . - Removable partials . and can be used for - Telescopic and milling work . Porta SMK 82 can be veneered with suitable dental ceramics as well as with dentalcomposites.

Device Story

Porta SMK 82 is a gold-palladium ceramic alloy (90.5% noble metals) used by dental technicians to fabricate dental restorations; includes crowns, bridges, and removable partials. Material is copper-free, facilitating telescopic and milling applications. Device is processed by dental technicians in a laboratory setting; can be veneered with dental ceramics or composites. Provides high corrosion resistance and biocompatibility for permanent dental appliances.

Clinical Evidence

Bench testing only. Compliance with international standard ISO 9693 and European directive 93/42/ECC demonstrated.

Technological Characteristics

Gold-palladium ceramic alloy; 90.5% noble metal content; copper-free. Complies with ISO 9693. Form factor: dental alloy for casting/milling. No software or electronic components.

Indications for Use

Indicated for patients requiring dental restorations including partial crowns, crowns, short span bridges, long span bridges, and removable partials. Suitable for telescopic and milling work.

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

• Deva Plus (K921419)

Submission Summary (Full Text)

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K012828

### Premarket Notification 510(k)

Porta SMK 82

NOV 0 1 2001

## 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:

Trade name:

. .

Porta SMK 82

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

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

Legally marketed equivalent device: Deva Plus K 921419 510(k) number:

#### Device description

Porta SMK 82 is a gold-palladium ceramic alloy with high contents of noble metals (90.5%), intended for dental technicians to fabricate dental restorations.

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

Porta SMK 82 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 SMK 82 can be veneered with suitable dental ceramics and with dental composites.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 1 2001

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

Re: K012828

Trade/Device Name: Porta SMK 82, Model 2032 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. Of the Act of ally I oderal banks and series and submitted to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 CFR Part 007), accling (QS) regulation (21 CFR Part 820); and if requirements as bet form in ontrol qt 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 110(k) premarket notification. The FDA finding of substantial equivalence of your device to 310(K) premium noticate 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 If You desire possible as a read 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and Office of Compliance at e, 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 the Act may be occained 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 Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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# NOV 01 2001

K012828

Premarket Notification 510(k)

Porta SMK 82

## 4. Statement of indication for use

Porta SMK 82 is a gold-palladium ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients.

It is intended for manufacturing

- Partial crowns .
- Crowns .
- Short span bridges .
- Long span bridges .
- Removable partials .

and can be used for

- Telescopic and milling work .
Porta SMK 82 can be veneered with suitable dental ceramics as well as with dentalcomposites.

Susan Runyon

(Division Sign-Off) Division Sign-Only
Division of Dental, Infection Control,
Division of Dental, Infections end General Hospital I ා ( O(k) Number --