(81 days)
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.
Radiance Porcelain system is a sodium/potassium alumina silicate based leucite glass ceramic, porcelain system for the fabrication of either porcelain fused to metal or all ceramic restorations. Radiance porcelain can only be used with its corresponding leucite glass ceramic pressable, Press-I-Dent for the fabrication of all ceramic systems and therefore constitute one complete porcelain system.
The provided text is a 510(k) summary for the Radiance Porcelain device, which is a dental material. It describes the device, its intended use, and its technological characteristics in comparison to predicate devices. However, this document does not contain information about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
The document states:
- "All the components in the Radiance System have been used in legally marketed devices."
- "This system has been on the European market since 1999 and enjoys full CE marking from the manufacturer."
- "Because of the similarities between the Radiance System and the predicated devices, we felt that no further biocompatibility testing was necessary."
- "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."
This indicates that the FDA's substantial equivalence determination for this device was based on similarity to legally marketed predicate devices and existing market history in Europe, not on a performance study against specific acceptance criteria. The document highlights "lower opposing occlusal wear characteristics" as an additional feature compared to feldspar-based porcelains but doesn't provide specific quantitative data or a study design to support this.
Therefore, I cannot populate the requested table and answer the study-related questions for this document because the information is not present. The provided text is a regulatory submission focused on demonstrating substantial equivalence based on material composition and intended use similar to existing products, rather than a detailed performance study with acceptance criteria.
{0}------------------------------------------------
Image /page/0/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 written in bold, sans-serif font.
P.O. Box 7200 • Fullerton, California 92834
(800) 422-7373 • (714) 523-5544
FAX (714) 870-0608
| DEC 17 2004510(k) Summary: | ||
|---|---|---|
| Contact: | Bruce D. Spivack | |
| Date Prepared: | September 22, 2004 | |
| Device Classification Name: | Class II, Porcelain Powder for Clinical Use(872.6660), EIH | |
| Trade Name: | Radiance Porcelain | |
| Predicate Devices: | Willi Geller Creation Porcelain, K981490Finesse Low Fusing Porcelain, K954761Vita Omega Porcelain, K921474 | |
| Device Description: | Radiance Porcelain system is a sodium/potassium aluminasilicate based leucite glass ceramic, porcelain system for thefabrication of either porcelain fused to metal or all ceramicrestorations. Radiance porcelain can only be used with itscorresponding leucite glass ceramic pressable, Press-I-Dent forthe fabrication of all ceramic systems and therefore constituteone complete porcelain system. | |
| Intended Use: | Radiance Porcelain is intended for the fabrication of dentalrestorations, crowns, bridges, veneers, inlays, and onlays, usingeither dental alloys or its pressable component, Press-I-Dent. | |
| Technological Characteristics: | All the components in the RadianceSystem have been used in legally marketed devices. Thissystem has been on the European market since 1999 and enjoysfull CE marking from the manufacturer. Because of thesimilarities between the Radiance System and the predicateddevices, we felt that no further biocompatibility testing wasnecessary |
27
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by three parallel lines curving upwards, resembling a stylized wing or feather design. The text is arranged in a circular pattern around the symbol, with "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" clearly visible.
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.
{2}------------------------------------------------
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
{3}------------------------------------------------
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 (800) 422-7373 · (714) 523-5544 FAX (714) 870-0608
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
Page 1 of . -
§ 872.6660 Porcelain powder for clinical use.
(a)
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.(b)
Classification. Class II.