← Product Code [EJS](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS) · K012841

# DUO PAL 6, ORDER-NO.: 2154 (K012841)

_Wieland Edelmetalle GmbH & Co. · EJS · Nov 20, 2001 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K012841

## Device Facts

- **Applicant:** Wieland Edelmetalle GmbH & Co.
- **Product Code:** [EJS](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS.md)
- **Decision Date:** Nov 20, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3060
- **Device Class:** Class 2
- **Review Panel:** Dental

## Intended Use

Duo Pal 6 is a palladium-gold ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Crowns . Short span bridges . Long span bridges . Removable partials . and can be used for Telescopic and milling work ● Duo Pal 6 can be veneered with suitable dental ceramics as well as with dentalcomposites.

## Device Story

Duo Pal 6 is a high-noble (81.5%) palladium-gold dental alloy used by dental technicians in a laboratory setting to fabricate dental restorations. The alloy is cast or milled to form crowns, bridges, and removable partials. It is copper-free, enhancing suitability for telescopic and milling applications. The finished restorations are veneered with dental ceramics or composites. The device provides a biocompatible, corrosion-resistant framework for dental prosthetics, aiding in the restoration of patient oral function and aesthetics.

## Clinical Evidence

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

## Technological Characteristics

High-noble dental alloy (81.5% noble metal content). Copper-free. Complies with ISO 9693. Suitable for veneering with dental ceramics and composites. Form factor: dental alloy for laboratory fabrication.

## Regulatory 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

- Cerapall 6 ([K911669](/device/K911669.md))

## Submission Summary (Full Text)

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## NOV 2 0 2001

#### Premarket Notification 510(k)

#### Duo Pal 6

# KO/2841

#### 5. 510 (k) Summary

| Submitter of 510(k): | Wieland Edelmetalle GmbH & Co. |
|----------------------|--------------------------------|
|                      | Schwenninger Str. 13           |
|                      | D-75179 Pforzheim              |
|                      | Germany                        |
|                      | Phone: +49-7231-3705-0         |

| Contact person: | Dr. Gerhard Polzer               |
|-----------------|----------------------------------|
| Phone:          | +49-7231-3705-219                |
| Fax:            | +49-7231-357959                  |
| e-mail:         | gerhard.polzer@wieland-dental.de |

2001-07-21 Date of Summary:

Trade name: Duo Pal 6

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

Alloy, precious metal, for clinical use EJS 872.3060 Class II

Legally marketed Cerapall 6 equivalent device: K 911669 510(k) number:

#### Device description

Duo Pal 6 is a dental alloy with high contents of noble metals (81,5%) intended for dental technicians to fabricate dental restorations.

it has an indication which ranges from 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.

Duo Pal 6 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.

Duo Pal 6 can be veneered with suitable dental ceramics and with dental composites.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2001

Dr. Gerhard Polzer Director Regulatory Affairs Wieland Edelmetalle GmbH & Co Schwenninger Strabe 13 Pforzheim, GERMANY

Re: K012841

Trade/Device Name: Duo Pal 6 Regulation Number: 872.3060 Regulation Name: Alloy, Precious Metal, For Clinical Use Regulatory Class: II Product Code: EJS Dated: August 23, 2001 Received: August 23, 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 (1) 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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Page 2 - Dr. Polzer

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Directo Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K012841

### Premarket Notification 510(k)

Duo Pal 6

## NOV 2 0 2001

### 4. Statement of indication for use

Duo Pal 6 is a palladium-gold ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients.

It is intended for manufacturing

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

and can be used for

- Telescopic and milling work ●
Duo Pal 6 can be veneered with suitable dental ceramics as well as with dentalcomposites.

Susan Cooper

(Division Sign-Off) (Division of Dental, Infection Control,
Division of Dental, Infection Control, Division of General Hospital and Good Cooper -

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