PORTA SOLDER 1090 W

K040524 · Wieland Dental + Technik GmbH & Co. KG · EJT · May 20, 2004 · Dental

Device Facts

• Record ID: K040524
• Device Name: PORTA SOLDER 1090 W
• Applicant: Wieland Dental + Technik GmbH & Co. KG
• Product Code: EJT · Dental
• Decision Date: May 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2

Intended Use

Porta Solder 1090 W is intended for use as a solder before firing in operations in which dental ceramic alloy(s) parts are joined to form a dental restoration. It should be used only together with recommended dental alloys with suitable melting ranges and compositions

Device Story

Porta Solder 1090 W is a white, precious metal-based dental brazing alloy (Gold, Palladium, Iridium, Silver: 95.5%). Used by dental technicians in a laboratory setting to join dental alloy components for restorations like bridges. Acts as a filler material during the soldering process before ceramic firing. Highly corrosion-resistant. Benefits patient by enabling the fabrication of durable, biocompatible dental restorations.

Clinical Evidence

Bench testing only. The device complies with international standard ISO 9333 for dental brazing alloys.

Technological Characteristics

Gold-based dental brazing alloy containing Gold, Palladium, Iridium, and Silver (95.5% total precious metal content). Formulated for high corrosion resistance. Complies with ISO 9333. No software or electronic components.

Indications for Use

Indicated for use by dental technicians to join dental ceramic alloy parts to form dental restorations, such as bridges, prior to firing. Requires use with compatible dental alloys.

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

• Argesol-WSF (K942505)

Submission Summary (Full Text)

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**MAY 20 2004**

K040524

# Premarket Notification 510(k)

# Porta Solder 1090 W

### 5. 510 (k) Summary

| 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] |

Date of Summary: 2004-02-18

Trade name:

PORTA SOLDER 1090 W

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

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

Legally marketed equivalent device: Argesol-WSF 510(k) number: K 942505

#### Device description

Porta Solder 1090 W is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a white alloy with high contents of precious metals (Gold, Palladium, Iridium and Silver: 95,5%).

Porta Solder 1090 W is suitable for use as a filler material in operations in which dental alloy(s) parts are joined to form a dental restoration, e.g. bridges.

It is intended as solder before firing for ceramic dental alloys with appropriate melting ranges and compositions, especially Euro 50, which is manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany.

Porta Solder 1090 W is highly corrosion resistant. It fully complies to the international standard ISO 9333 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling an emblem. The emblem is a stylized depiction of an eagle with three lines representing its wings.

MAY 2 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Gerhard Polzer Regulatory Affairs Wieland Dental + Technik GmbH & Company KG Schwenninger Strabe 13 D-75179 Pforzheim GERMANY

Re: K040524

Trade/Device Name: Porta Solder 1090 W Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: February 16, 2004 Received: March 1, 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 promarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions 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 wr t), ice 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 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 and instille (s 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) rms retect 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), 11 you 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 your responsibilities under the Act 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,

Chris Linsell, Ph.D.

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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Page !

510(k) Number (if known) : _

Device Name: Porta Solder 1090 W

Indications For Use:

Porta Solder 1090 W is intended for use as a solder before firing in operations in which dental ceramic alloy(s) parts are joined to form a dental restoration.

It should be used only together with recommended dental alloys with suitable melting ranges and compositions

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Saset Rums

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental De

510(k) Number:

(Optional Format 3-10-98)

Prescription Use
(Per 21 CFR 801.109)