(236 days)
The Glass 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
I am sorry, but the provided text is a 510(k) clearance letter for a dental device (Glass Post) and does not contain information about acceptance criteria or a study proving device performance using AI. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail any performance studies, acceptance criteria, or AI-related evaluations. It is a regulatory approval, not a technical performance report.
Therefore, I cannot provide the requested information based on the input text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2002
J. Morita USA, Incorporated C/O Mr. Keith A. Barritt Fish & Richardson 601 13th Street, NW Suite 500 North Washington, DC 20005
Re: K012849
Trade/Device Name: Glass Post Regulation Number: 872.3810 Regulation Name: Root Canal Post Regulatory Class: I Product Code: ELR Dated: January 16, 2002 Received: January 17, 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 T ou must comply with an any labeling (21 CFR Part 801); good manufacturing practice allo fisting (21 CF Prav 807), and ity 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 I his letter will and w you to eagle in the FDA finding of substantial equivalence of your device to 310(K) promained nouricate 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 If you desire up 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the and additionally 21 CF ( 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 nothernon- (21 St 11:21 and from the Division of Small Manufacturers, International and the Net ind be obtained 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,
A. Ulatowski Timoth 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): Device Name: Glass Post Indications For Use:
The Glass 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 كري
OR
Over-The-Counter Use __
(Per 21 CFR 801.109)
Swar Kunre
(Division Sign-Off) Division of Dental, Infection Control,
Division of Dental, Infection Control,
Division of Dental, Infection Devises | > C Division of Dental,
E10(k) Number -
7
§ 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.