BIOPORTA G

K023391 · Wieland Dental + Technik GmbH & Co. KG · EJT · Dec 10, 2002 · Dental

Device Facts

• Record ID: K023391
• Device Name: BIOPORTA G
• Applicant: Wieland Dental + Technik GmbH & Co. KG
• Product Code: EJT · Dental
• Decision Date: Dec 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2

Intended Use

BioPorta G is a gold-platinum 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 BioPorta G can be veneered with suitable dental ceramics as well as with dental-composites. In addition BioPorta G, in the shape of wires, can be used for laser welding in operations in which dental alloy parts made of BioPorta G are joined to form dental restorations.

Device Story

BioPorta G is a gold-platinum ceramic alloy (97% noble metal content); free of copper. Used by dental technicians in laboratory settings to fabricate dental restorations (inlays, onlays, crowns, bridges, removable partials). Material provides golden yellow base for aesthetic veneering with dental ceramics or composites. Supplied as ingots or laser welding wires for joining alloy parts. High corrosion resistance and biocompatibility. Clinical benefit: provides durable, aesthetically pleasing, biocompatible dental prosthetic foundation.

Clinical Evidence

Bench testing only. Device complies with ISO 9693 standards for dental ceramic fused to metal restorations and European directive 93/42/ECC requirements.

Technological Characteristics

Gold-platinum ceramic alloy; 97% noble metal content; copper-free. Form factor: ingots and laser welding wires. Complies with ISO 9693. Biocompatible, corrosion-resistant. No software or electronic components.

Indications for Use

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

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

• V-Gnathos Plus (K952122)

Submission Summary (Full Text)

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Premarket Notification 510(k)

## BioPorta G

Image /page/0/Picture/2 description: The image shows a handwritten sequence of characters. The sequence starts with the letters 'K' and 'O', followed by the number '2'. After '2', there are two '3's, and the sequence ends with '41'. The handwriting is somewhat rough, with varying stroke thicknesses.

#### 5. 510 (k) Summary

# DEC 1 0 2002

- Wieland Dental + Technik GmbH & Co. KG Submitter of 510(k): 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:

Trade name:

BioPorta G

2002-10-05

Classification name: Alloy, gold based, for clinical use Product code: EJT C.D.R section: 872.3060 Classification: Class II

Legally marketed V-Gnathos Plus equivalent device: 510(k) number: K952122

#### Device description

BioPorta G is a gold-platinum ceramic alloy with high contents of noble metals (97 %) 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 suitable for telescopic and milling work as well as for laser welding. For this application it will be delivered in the shape of laser welding wires.

BioPorta G 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.

BioPorta G can be veneered with suitable dental ceramics 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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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, with three overlapping profiles facing to the right. The profiles are rendered in black and white.

#### Public Health Service

ood and Drug Administ 200 Corporate Boulevari ockville MD 20850

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

Re: K023391

Trade/Device Name: BioPorta G Regulation Number: 21 CFR 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: October 05, 2002 Received: October 09, 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), 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

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510(k) Number (if known):

BioPorta G Device Name:

Indications For Use:

BioPorta G is a gold-platinum alloy that can be used by dental technicians to fabricate der 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
BioPorta G can be veneered with suitable dental ceramics as well as with dental-composites.

In addition BioPorta G, in the shape of wires, can be used for laser welding in operations in which dental alloy parts made of BioPorta G are joined to form dental restorations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use✓<br>(Per 21 CFR 801.109) | |
|-------------------------------------------|--|
|-------------------------------------------|--|

OR

| | Over-The-Counter Use ______ |
|--|-----------------------------|
|--|-----------------------------|

| | (Optional Format 1-2-96) |
|---------------|------------------------------------------------------------------------------------|
| | <i>Susan Runore</i> |
| | (Division Sign-Off) |
| | Division of Anesthesiology, General Hospital,<br>Infection Control, Dental Devices |
| 510(k) Number | k.023391 |