MINERVA 58 ALLOY

K032318 · Dentsply International · EJT · Sep 30, 2003 · Dental

Device Facts

• Record ID: K032318
• Device Name: MINERVA 58 ALLOY
• Applicant: Dentsply International
• Product Code: EJT · Dental
• Decision Date: Sep 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MINERVA 58 ALLOY is indicated as a dental alloy for fabricating MOD inlays, crowns, bridges, precision milling bars and attachments, and partial dentures.

Device Story

Minerva 58 Alloy is a high noble, gold-based dental alloy used by dental professionals for the fabrication of various dental restorations, including MOD inlays, crowns, bridges, precision milling bars, attachments, and partial dentures. The alloy is processed in a dental laboratory setting to create custom dental prosthetics. It serves as a restorative material to replace missing tooth structure or support dental appliances, benefiting patients by providing durable, biocompatible dental restorations. The device relies on established metallurgical properties of gold-based alloys.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by historical use in the European market since 1987 and the use of components found in legally marketed devices.

Technological Characteristics

High noble, gold-based dental alloy. Compositional components are consistent with legally marketed dental alloys. No specific ASTM standards or software/connectivity features are described.

Indications for Use

Indicated for dental patients requiring fabrication of MOD inlays, crowns, bridges, precision milling bars, attachments, and partial dentures.

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

• Stabilor G Alloy (K951782)

Submission Summary (Full Text)

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## 510(k) SUMMARY

Image /page/0/Picture/1 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and black. The letter "N" has a unique design, with a sharp, angled cut in the middle. The word is horizontally oriented and appears to be a logo or brand name.

NAME & ADDRESS:

SEP 3 0 2003

K032318

West ( ollege Avenue PA 17405-087 w.dentsplv.com

P. J. Lehn Telefax [phone]

P. Jeffery Lehn CONTACT:

DATE PREPARED: July 25, 2003

TRADE OR PROPRIETARY NAME: MINERVA 58 ALLOY

CLASSIFICATION NAME: Gold-based alloy for clinical use (872.3060)

PREDICATE DEVICES: Stabilor G Alloy K951782

DEVICE DESCRIPTION: MINERVA 58 ALLOY is a high noble, gold-based dental alloy.

INTENDED USE: MINERVA 58 ALLOY is indicated as a dental alloy for fabricating MOD inlays, crowns, bridges, precision milling bars and attachments, and partial dentures.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in MINERVA 58 ALLOY have been used in legally marketed devices.

MINERVA 58 ALLOY is very similar in formulation to legally marketed dental alloys. This alloy has been on the European market since 1987 with over 800.000 units placed. Therefore, it was determined that no biocompatibility testing was necessary.

We believe that the prior use of the components of MINERVA 58 ALLOY in legally marketed devices, the performance data provided, and the historical use of the device in Europe support the safety and effectiveness of MINERVA 58 ALLOY for the indicated uses.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure, represented by three curved lines, with a bird-like shape above it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 3 0 2003

Mr. P Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872

Re: K032318

Trade/Device Name: Minerva 58 Alloy Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: July 25, 2003 Received: July 28, 2003

Dear Mr. Lehn:

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 - Mr. Lehn

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 (OS) 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 vour 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]. 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,

Susa Rumrr

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

Enclosure

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## INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 807.87(e)

510(K) Number (if known):

Device Name:

MINERVA 58 ALLOY

Indications for Use:

Fabricating MOD inlays, crowns, bridges, precision milling bars and attachments, and partial dentures.

A.E.Soffe for MSR

nesthesiology, General Hospital. ntrol, Dental Devices

510(k) Number: K032318

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)