(81 days)
Not Found
No
The 510(k) summary describes a dental porcelain system and does not mention any AI or ML technology.
No
The device is a dental porcelain system used for fabricating restorations, crowns, bridges, veneers, inlays, and onlays, not for therapeutic purposes.
No
Explanation: The device is a dental porcelain system used for fabricating restorations, crowns, bridges, veneers, inlays, and onlays. It is a material used for treatment, not for diagnosing a condition.
No
The device is a physical material (porcelain system) used for fabricating dental restorations, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication of dental restorations (crowns, bridges, veneers, etc.) using a porcelain system. This is a manufacturing process for a medical device (the dental restoration), not a diagnostic test performed on a biological sample.
- Device Description: The description details the composition and use of the porcelain system for creating dental restorations. It does not describe a test or assay for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a material used in the creation of a medical device (a dental restoration), which is then placed in the patient. This falls under the category of a dental material or a component of a dental prosthesis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 2004
| 510(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, K981490 | |
| Finesse Low Fusing Porcelain, K954761 | ||
| Vita Omega Porcelain, K921474 | ||
| Device Description: | 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. | ||
| 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. | ||
| Technological Characteristics: | 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 |
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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
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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 (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
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