PORTA REFLEX

K040672 · Wieland Dental + Technik GmbH & Co. KG · EJT · May 27, 2004 · Dental

Device Facts

• Record ID: K040672
• Device Name: PORTA REFLEX
• Applicant: Wieland Dental + Technik GmbH & Co. KG
• Product Code: EJT · Dental
• Decision Date: May 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2

Intended Use

Porta Reflex 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 Porta Reflex can be veneered with suitable dental ceramics as well as with dental-composites.

Device Story

Porta Reflex is an extra-hard gold-platinum ceramic alloy (97.7% noble metals); copper-free. Used by dental technicians to fabricate dental restorations including inlays, onlays, crowns, bridges, and removable partials. Material is veneered with dental ceramics or composites to create aesthetic restorations. High corrosion resistance and biocompatibility. Used in dental laboratory settings for restorative dentistry; provides structural basis for dental appliances.

Clinical Evidence

No clinical data. Substantial equivalence is based on material composition, physical properties, and compliance with international standards (ISO 9693) for dental alloys.

Technological Characteristics

Extra-hard gold-platinum alloy; 97.7% noble metal content; copper-free. Complies with ISO 9693. High corrosion resistance and biocompatibility. Formulated for veneering with dental ceramics or composites.

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 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

• Porta Geo Ti (K023389)

Submission Summary (Full Text)

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K040672

MAY 2 7 2004

## Premarket Notification 510(k)

## Porta Reflex

## 510 (k) Summary 5.

| 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] |

2004-02-16 Date of Summary:

Trade name:

Porta Reflex

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

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

Legally marketed equivalent device: Porta Geo Ti K 023389 510(k) number:

## Device description

Porta Reflex is an extra-hard gold-platinum ceramic alloy with high contents of noble metals (97,7%), 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 removable partials. It is free of copper and therefore suitable for telescopic and milling work.

Porta Reflex 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 Reflex 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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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings. The eagle is facing left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 27 2004

Dr. Gerhard Polzer Regulatory Affairs Wieland Dental+ Technik GmbH & Company KG Schwenninger Strabe 13 D-75 179 Pforzheim GERMANY

Re: K040672

Trade/Device Name: Porta Reflex Regulation Number: 872.3060 Regulation Namc: Gold-Based Alloys and Precious Metal Alloys for Clinical USE Regulatory Class: II Product Code: EJT Dated: February 16, 2004 Received: March 15, 2004

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. 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 modified in any Federal statutes and regulations administered by other Federal agencies. or the rice of any - 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 and home (21 CF R Part 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) This letter whilanov. Jo The FDA finding of substantial equivalence of your device to a premaired notified predicate device results in a classification for your device and thus, permits your device to procced to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you decire 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 your responsibilities under the Act from the maj obtain 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,

Chiu Lin, Ph.D.

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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510(k) Number (if known): K040672

Device Name: Porta Reflex

Indications For Use:

Porta Reflex 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 ·

Porta Reflex can be veneered with suitable dental ceramics as well as with dental-composites.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumm

ivision of Ar

510(k) Number: K040672

(Optional Format 3-10-98)