V-GNATHOS SUPRA

K013769 · Metalor Technologies USA · EJT · Jan 22, 2002 · Dental

Device Facts

• Record ID: K013769
• Device Name: V-GNATHOS SUPRA
• Applicant: Metalor Technologies USA
• Product Code: EJT · Dental
• Decision Date: Jan 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Substructures for porcelain-to-metal crowns and bridges. Suprastructures on implants, milling works.

Device Story

V-Gnathos Supra is a dental alloy used as a substructure for porcelain-to-metal crowns and bridges, or as a suprastructure for dental implants. It is intended for use in dental laboratories by technicians to fabricate custom dental restorations. The device is processed via milling or casting techniques to create the final prosthetic shape. Once fabricated, the restoration is placed by a dentist to restore patient dentition or support implant-retained prosthetics. The device provides a structural framework for porcelain application, improving the durability and fit of dental restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental alloy for porcelain-to-metal restorations. Form factor: metal ingots/discs for milling or casting. Material composition and physical properties consistent with standard dental casting alloys (Class II, Product Code EJT).

Indications for Use

Indicated for use as substructures for porcelain-to-metal crowns and bridges, and as suprastructures on dental implants or for milling works.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2002

Mr. Bruce A. Barton Official Correspondent Metalor Technologies USA Dental Division 255 John L. Dietsch Boulevard North Attleborough, Massachusetts 02761

Re: K013769

Trade/Device Name: V-Gnathos Supra Regulation Number: 872.3060 Regulation Name: Metalor V-Gnathos Supra Regulatory Class: II Product Code: EJT Dated: November 8, 2001 Received: November 13, 2001

Dear Mr. Barton:

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.

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 - Mr. Barton

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 [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

Timot A. Ulatowsk Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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| 510(k) Number (if known): | K013-769 |
|---------------------------|-----------------|
| Device Name: | V-Gnathos Supra |
| Indications For Use: | |

Substructures for porcelain-to-metal crowns and bridges. Suprastructures on implants, milling works.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

IDivision Sign-Off) Division of Dental, Infection Control. and General Hospital Devices 269 510(k) Number --

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_

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