(16 days)
Coltène Cool Temp Natural, in Vita® shades A1, A2 and A3.5, is indicated for temporary crown- and bridge restorations used for all techniques, i.e. with matrices or templates as well as Direct application in the dental laboratory.
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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental material (Cool Temp Natural), not a study report for an AI/ML medical device.
Therefore, I cannot extract any information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details as requested. The document does not contain any of these elements.
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Image /page/0/Picture/1 description: The image is a black and white emblem for the U.S. Department of Health and Human Services. The emblem features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The emblem is simple and conveys a sense of official government affiliation.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2004
Coltene AG C/O Mr. H. J. Vogelstein Official Correspondent Henry J. Vogelstein 1349 Lexington Avenue New York, 10128
Re: K041098
Trade/Device Name: Cool Temp Natural Regulation Number: 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: April 24, 2004 Reccived: April 27, 2004
Dear Mr. Vogelstein:
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 approvisions of the Act. The general controls provisions of the Act include controls provisions of a registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Writ), it har be basyon in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be foundsh further announcements concerning your device in the Ecderal Register.
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Page 2 -Mr. Vogelstein
Please be advised that FDA's issuance of a substantial equivalence determination does not I least be advised that I Dr. o lessment on that your device complies with other requirements moan that i Dr mas made statutes and regulations administered by other Federal agencies. of the Act of ally I ederal lithe Act's requirements, including, but not limited to: registration r ou must comply with as a so7); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 007), assility systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quadiation 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) This letter with are n Jour of Job finding of substantial equivalence of your device to a premitser notified on - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at Compliance at (301) 594-4613. 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 may outlife 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,
Qur
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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Coltène AG 510(k) Submission
Page 1/1
Indications for Use
| 510(k) Number (if known): | K041098 |
|---|---|
| --------------------------- | --------- |
Device Name: Cool Temp Natural
Indications for Use:
Coltène Cool Temp Natural, in Vita® shades A1, A2 and A3.5, is indicated for
es in the contraction is to the starsting used for all techniques, i e Collene Cool Temp Natural, in Vita - only in with matriages, i.e.i.
temporary crown- and bridge restorations used for with matrings or term temporary crown- and bridge restorations asonor of of teachines or templates as well as Direct application in the dental laboratory.
Prescription Use (21 CFR Part 801 Subpart D) Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Super Runser
AND/OR
(Division Sian-Off) Division of Anesthesiology, General Hospi Infection Control, Dental De
510(k) Number: K041098
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.