(51 days)
FENIIIIIX system includes the following 6 sets of stains and dental porcelains:
FENIIIIIX COLORATION KIT SN2000Y a porcelain stain system designed for easy application and natural fluorescent properties. This dental porcelain stain system can be used with most commercially available porcelain restorations where porcelain's ability to mimic natural tooth appearance is important. The system provides optimum esthetics with the most consistently reliable results for the full range of shades.
The FENIIIIIX COLORATION KIT stain system is ideal for high and low production laboratories and is available in 16 classic Vita® shades as well as Neutral Brown, Complex Gray, Blue Gray, Ochre; Rust and Red for matching bleached dentition with CTE Ranges of 13.7 to 15.1. The full assortment is 22 Stains, 1 powdered glaze and 1 liquid glaze.
The stains in the SN2000Y kit fire at 900ºC
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FENIIIIIX COLORATION KIT SN200Y is identical to the SN2000Y kit in function and content except that the stains in the SN2000Y kit fire at 750°C
FENIIIIIX SUPER LIGHT WHITE KIT, a stain kit designed to produce perfectly white dental restorations. It includes one powdered stain and 1 liquid glazon -
FENIIIIIX SPEACIAL CLEAR KIT, This kit includes a series of whites designed to produce areas of whitish translucence and opalescence.
-
ASTARTE SUPER WHITE PORCELAIN KIT. This kit is specifically designed to create perfectly white dental restorations and can be used with most commercially available base and precious metal, dental alloys that are designed for porcelain fused to metal applications. It includes 1 powdered opaque, 1 powdered enamel, 1 powdered colorless glaze, 1 liquid opaque and 1 liquid dentine.
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FENI///// ELIMINCRACK. This kit is used to repair cracks that form in porcelain dental restorations. It includes 1 powdered porcelain and 1 repair liquid.
Not Found
I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) premarket notification for a dental porcelain product named FENIIIIIIX. It describes the product's indications for use and states that it has been deemed substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details related to assessing the performance of a device using AI or human readers.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or any other details about studies as none of that information is present in the text you've provided.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three human profiles facing to the right, with flowing lines beneath them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 MAR 3
Mr. Masimo Sasso President Dental Arte, Incorporated 12315 Oak Knoll Road, Suite 330 Poway, California 92064-5343
Re: K060086
Trade/Device Name: FENIIIIIIX Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: February 22, 2006 Received: February 22, 2006
Dear Mr. Sasso:
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 coominer co 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 Nosmetic 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. Massio Sasso
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 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" (21 CFR 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/industry/support/index.html.
Sincerely vours,
Syra Sunnes
Chiu S. Lin, PhD 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/2/Picture/1 description: The image shows the logo for Dental Arte. The logo is in black and white and features the company name in a bold, sans-serif font. Below the name is the tagline "Equipment for Dentistry, Worldwide" in a smaller font.
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INDICATIONS FOR USE:
510(k) Number (if known):
Device Name: FENIIIIIX
Indications for Use: FENIIIIIX system includes the following 6 sets of stains and dental porcelains:
FENIIIIIX COLORATION KIT SN2000Y a porcelain stain system designed for easy application and natural fluorescent properties. This dental porcelain stain system can be used with most commercially available porcelain restorations where porcelain's ability to mimic natural tooth appearance is important. The system provides optimum esthetics with the most consistently reliable results for the full range of shades.
The FENIIIIIX COLORATION KIT stain system is ideal for high and low production laboratories and is available in 16 classic Vita® shades as well as Neutral Brown, Complex Gray, Blue Gray, Ochre; Rust and Red for matching bleached dentition with CTE Ranges of 13.7 to 15.1. The full assortment is 22 Stains, 1 powdered glaze and 1 liquid glaze.
The stains in the SN2000Y kit fire at 900ºC
- FENIIIIIX COLORATION KIT SN200Y is identical to the SN2000Y kit in function and content except that the stains in the SN2000Y kit fire at 750°C
FENIIIIIX SUPER LIGHT WHITE KIT, a stain kit designed to produce perfectly white dental restorations. It includes one powdered stain and 1 liquid glazon
Prescription Use X and/or Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rumer
New York General Hospital
Dental Services
Traditional 510(k)
FENIIIIIIX
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Image /page/3/Picture/0 description: The image shows the logo for Dental Arte Inc. The logo is in black and white and features the company name in a bold, sans-serif font. Below the name is the tagline "Equipment for Dentists, worldwide" in a smaller font.
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INDICATIONS FOR USE (Continued):
- FENIIIIIX SPEACIAL CLEAR KIT, This kit includes a series of whites designed to produce areas of whitish translucence and opalescence.
- ASTARTE SUPER WHITE PORCELAIN KIT. This kit is specifically designed to create perfectly white dental restorations and can be used with most commercially available base and precious metal, dental alloys that are designed for porcelain fused to metal applications. It includes 1 powdered opaque, 1 powdered enamel, 1 powdered colorless glaze, 1 liquid opaque and 1 liquid dentine.
- FENI///// ELIMINCRACK. This kit is used to repair cracks that form in porcelain dental restorations. It includes 1 powdered porcelain and 1 repair liquid.
X Prescription Use and/or Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
Traditional 510(k)
FENIIIIIIII
§ 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.