(287 days)
The Carbon Post is a root canal post for use with composite resin cement in a prepared root canal in a non-vital tooth to stabilize and support a restoration.
Not Found
The provided text is a 510(k) premarket notification FDA letter for a device called "Carbon Post." This document is a regulatory approval letter and does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information based on the input text. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed, but it does not detail the scientific studies or performance data that would typically be associated with such a submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
MAY 1 7 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
J. Morita USA, Incorporated C/O Mr. Keith A. Barritt Fish & Richardson P.C. 601 13th Street, N.W. Washington, DC 20005
Re: K012496
Trade/Device Name: Carbon Post Regulation Number: 872.3810 Regulation Name: Root Canal Post Regulatory Class: I Product Code: ELR Dated: March 6, 2002 Received: March 7, 2002
Dear Mr. Barritt:
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.
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.
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Page 2 - Mr. Barritt
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Patrice Cusenier/for
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): KO)Q496 Device Name: Carbon Post Indications For Use:
The Carbon Post is a root canal post for use with composite resin cement in a prepared root canal in a non-vital tooth to stabilize and support a restoration.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
Susan Ranns
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic F 11/9) Number _______________________________________________________________________________________________________________________________________________________________
§ 872.3810 Root canal post.
(a)
Identification. A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.