(11 days)
inCoris AL are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; for single unit anterior or posterior crowns and 3 unit anterior bridges.
Not Found
I am sorry, but the provided text does not contain the acceptance criteria, device performance, or details about a study to prove the device meets these criteria. The document is a 510(k) clearance letter from the FDA for the "inCoris AL" device, indicating that it has been found substantially equivalent to a legally marketed predicate device.
The document includes:
- Trade/Device Name: Incoris AL
- Regulation Number: 21 CFR 872.6660
- Regulation Name: Porcelain Powder for Clinical Use
- Regulatory Class: II
- Product Code: EIH
- Indications for Use: as a substructure for porcelain fused ceramic fixed dental restorations; for single unit anterior or posterior crowns and 3 unit anterior bridges. Substructures of inCoris AL for CEREC are machined using the CEREC 2, CEREC 3 and inLab CAD/CAM systems.
However, it does not provide any specific information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test sets.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory approval letter, not a scientific study report or a summary of performance data.
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SEP - 8 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sirona Dental Systems GmbH C/O Mr. Stefan Preiss Responsible Third Party Official TUV America, Incorporated 1775 Old Highway 8 New Brighton, Minnesota 55112-1891
Re: K062506
Trade/Device Name: Incoris AL Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: August 25, 2006 Received: August 28, 2006
Dear Mr. Preiss:
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. Preiss
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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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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510(k) Number (if known):
Device Name: _____________inCoris AL
Indications for Use:
inCoris AL are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; for single unit anterior or posterior crowns and 3 unit anterior bridges.
Substructures of inCoris AL for CEREC are machined using the CEREC 2, CEREC 3 and inLab CAD/CAM systems.
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Quast
ംസം Sign-Off) on of Anesthesiology, General Hospital, Juon Control, Dental Devices
Number: K012506
Sirona Dental Systems 510(k) inCoris AL
§ 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.