RADIANCE PORCELAIN

K042638 · Aurident, Inc. · EIH · Dec 17, 2004 · Dental

Device Facts

• Record ID: K042638
• Device Name: RADIANCE PORCELAIN
• Applicant: Aurident, Inc.
• Product Code: EIH · Dental
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Radiance Porcelain is intended for the fabrication of dental restorations, crowns, bridges, veneers, inlays, and onlays, using either dental alloys or its pressable component, Press-I-Dent.

Device Story

Radiance Porcelain is a sodium/potassium alumina silicate leucite glass ceramic system used by dental laboratories to fabricate dental restorations (crowns, bridges, veneers, inlays, onlays). The system functions either by application over dental alloys or via a pressable component, Press-I-Dent. It is a low-fusing porcelain manufactured from fritted glass compositions, designed to exhibit lower opposing occlusal wear compared to traditional feldspar-based porcelains. The device is used in a laboratory setting to create custom dental prosthetics, which are then placed by a clinician to restore patient dentition.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and historical use of components in legally marketed devices.

Technological Characteristics

Sodium/potassium alumina silicate leucite glass ceramic system. Low-fusing porcelain manufactured via fritting of glass compositions. Designed for use with dental alloys or Press-I-Dent pressable component. No specific ASTM standards or software components described.

Indications for Use

Indicated for use by dental laboratories for the fabrication of dental restorations including crowns, bridges, veneers, inlays, and onlays. No specific patient population age or gender restrictions are noted.

Regulatory Classification

Identification

Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

Predicate Devices

• Willi Geller Creation Porcelain (k981490)
• Finesse Low Fusing Porcelain (k954761)
• Vita Omega Porcelain (k921474)

Submission Summary (Full Text)

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K642638

P.O. Box 7200 • Fullerton, California 92834
[phone] • [phone]
FAX [phone]

| DEC 17 2004<br>510(k) Summary: | | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact: | Bruce D. Spivack | |
| Date Prepared: | September 22, 2004 | |
| Device Classification Name: | Class II, Porcelain Powder for Clinical Use<br>(872.6660), EIH | |
| Trade Name: | Radiance Porcelain | |
| Predicate Devices: | Willi Geller Creation Porcelain, k981490<br>Finesse Low Fusing Porcelain, k954761<br>Vita Omega Porcelain, k921474 | |
| Device Description: | Radiance Porcelain system is a sodium/potassium alumina<br>silicate based leucite glass ceramic, porcelain system for the<br>fabrication of either porcelain fused to metal or all ceramic<br>restorations. Radiance porcelain can only be used with its<br>corresponding leucite glass ceramic pressable, Press-I-Dent for<br>the fabrication of all ceramic systems and therefore constitute<br>one complete porcelain system. | |
| Intended Use: | Radiance Porcelain is intended for the fabrication of dental<br>restorations, crowns, bridges, veneers, inlays, and onlays, using<br>either dental alloys or its pressable component, Press-I-Dent. | |
| Technological Characteristics: | All the components in the Radiance<br>System have been used in legally marketed devices. This<br>system has been on the European market since 1999 and enjoys<br>full CE marking from the manufacturer. Because of the<br>similarities between the Radiance System and the predicated<br>devices, we felt that no further biocompatibility testing was<br>necessary | |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 17 2004

Mr. Bruce D. Spivack Manager, Sales and New Product Development Aurident, Incorporated 610 South College Boulevard Fullerton, California 92831

Re: K042638

Trade/Device Name: Radiance Porcelain Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: December 6, 2004 Received: December 9, 2004

Dear Mr. Spivack:

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. Spivack

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 (2 = = = = 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), 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,

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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Image /page/3/Picture/0 description: The image shows the logo for AURIDENT, INC. The logo consists of a four-pointed star to the left of the company name. The company name is in bold, sans-serif font.

P.O. Box 7200 · Fullerton, California 92834 [phone] · [phone] FAX [phone]

## Indications for Use

510(k) Number (if known): K042638

Device Name: Radiance Porcelain

Indications For Use:

Radiance Porcelain is a sodium/potassium alumina silicate leucite glass ceramic porcelain system for the fabrication of dental restorations, crowns, bridges, veneers, inlays, and onlays, using either dental alloys or its pressable component, Press-I-Dent.

This porcelain system is a lower fusing porcelain than feldspar based porcelains and is manufactured from the fritting of manufactured glass compositions. In addition, it has lower opposing occlusal wear characteristics than feldspar based porcelains.

Radiance is intended for use by dental laboratories as an alternative to other porcelains.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Quasar

Asion Sir n-Oif) (Chasion Sign-Oit)
Division of Anesthes Ology, General Hospital.
Division of Anesthes Davices ാന്ത്രിക്കുന്നത്. Dental Dental Dental Dental Dental

Mumber

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