PORTA PRESSOVER

K031264 · Wieland Dental + Technik GmbH & Co. KG · EJT · Jun 12, 2003 · Dental

Device Facts

• Record ID: K031264
• Device Name: PORTA PRESSOVER
• Applicant: Wieland Dental + Technik GmbH & Co. KG
• Product Code: EJT · Dental
• Decision Date: Jun 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2

Intended Use

Porta PressOver is a gold-silver-palladium alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Inlays/Onlays, Crowns, Short span bridges and can be used for Telescopic and milling work. Porta PressOver can be utilized as a conventional casting alloy, in which it can be veneered with dental composites, as well as a ceramic alloy, which has to be veneered (pressed over) by the IMAGINE h.e. Press ceramic of Wieland Dental + Technik GmbH & Co. KG.

Device Story

Porta PressOver is a gold-silver-palladium (type 3) dental alloy; high noble metal content (76.5%). Used by dental technicians in laboratory settings to fabricate dental restorations including inlays, onlays, crowns, short span bridges, and telescopic/milling work. Functions as a conventional casting alloy (veneered with composites) or a ceramic alloy (veneered via PressOver-Technique with IMAGINE h.e. Press Ceramic). Provides corrosion resistance and biocompatibility for dental appliances. Output is a physical dental restoration used by dentists to restore patient dentition.

Clinical Evidence

No clinical data. Substantial equivalence is based on material composition, physical properties, and intended use compared to the predicate device.

Technological Characteristics

Gold-silver-palladium alloy (type 3); 76.5% noble metal content. High corrosion resistance and biocompatibility. Formulated for conventional casting or ceramic veneering (PressOver-Technique).

Indications for Use

Indicated for dental patients requiring inlays, onlays, crowns, short span bridges, or telescopic/milling restorations fabricated by dental technicians.

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 4CF (K911541)

Reference Devices

• IMAGINE h.e. Press ceramic

Submission Summary (Full Text)

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Premarket Notification 510(k)

## Porta PressOver

JUN 12 2003

## 5. 510 (k) Summary

K03264

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] |

2003-04-10

Date of Summary:

Trade name: Porta PressOver

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

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

Device description

Porta PressOver is a gold-silver-palladium alloy (type 3) with high contents of noble metals (76,5%) intended for dental technicians to fabricate dental restorations.

lt has an indication for use, which ranges from inlays/onlays and single crowns up to short span bridges with two pontics. In addition, it can be used for telescopic and milling work.

Porta PressOver can be utilized as a conventional casting alloy as well as a ceramic alloy, which has to be veneered by the Pressover-Technique with IMAGINE® h.e. Press Ceramic.

Porta PressOver is highly corrosion resistant and has an excellent biocompatibility. It meets all relevant essential requirements of the European directive 93/42/ECC concerning medical devices.

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Image /page/1/Picture/11 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 an abstract image of an eagle or bird-like figure with three horizontal lines forming the body and stylized waves below.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 2 2003

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

Re: K031264

Trade/Device Name: Porta PressOver Regulation Number: 21 CFR 872.3060 Regulation Name: Gold Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Codes: EJT Dated: April 17, 2003 Received: April 22, 2003

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) you may obtain. Other general information on vour 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,

Susan Punore

Susan Runner, DDS, MA Interim 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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| CR (IF KNOWN): | K03126 |
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Porta PressOver

DEVICE NAME :

510 (K) NUMBE

INDICATIONS FOR USE:

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

It is intended for manufacturing

- Inlays/Onlays .
- Crowns ●
- Short span bridges ●

and can be used for

- Telescopic and milling work .
Porta PressOver can be utilized as a conventional casting alloy, in which it can be veneered with dental composites, as well as a ceramic alloy, which has to be veneered (pressed over) by the IMAGINE h.e. Press ceramic of Wieland Dental + Technik GmbH & Co. KG.

(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)

Kei Muly for MSR

(Division Sign-C Division of Anesthesiology, General Hospital, Infection Control. Dental D

510(k) Number: K031264