(167 days)
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Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on a dental post for retention.
No
The device, FRC Postec, gives retention for reconstruction of endodontically treated teeth. This is a restorative function, not a therapeutic one which would involve treating a disease or disorder.
No
The device is described as providing "retention for reconstruction," which indicates a therapeutic or restorative purpose rather than identifying a disease or condition.
No
The provided 510(k) summary describes a device intended for use by dentists for retention in endodontically treated teeth. The description focuses on a physical product ("FRC Postec") and its intended use in a dental procedure, with no mention of software components, image processing, AI, or any other characteristics typically associated with a software-only medical device.
Based on the provided information, FRC Postec is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide retention for reconstruction of endodontically treated teeth. This is a dental procedure performed directly on the patient's teeth.
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. FRC Postec does not involve the examination of such specimens.
- Anatomical Site: The anatomical site is "endodontically treated teeth," which are part of the patient's body, not a specimen taken from the body.
Therefore, FRC Postec is a dental device used in a clinical setting, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
FRC Postec is intended for use by dentists to give retention for reconstruction of endontically treated teeth
Product codes
ELR
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three flowing lines representing the hair or head. The figure is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0-1 2002
Ms. Donna M. Hartnett Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228
Re: K013802
Trade/Device Name: FRC POSTEC Regulation Number: 872.3810 Regulation Name: Post, Root Canal Regulatory Class: I Product Code: ELR Dated: February 20, 2002 Received: February 26, 2002
Dear Ms. Hartnett:
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.
1
Page 2 -- Ms. Donna M. Hartnett
You must comply with all the Act's requirements, including, but not limited to: registration r od intere (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fisuling (21 et ready in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as betrenic 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 110(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 and cautionally July 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 alle Free may or stance 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,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
. #
| 510(k) Number (if known): | Pending K013802 |
|---|---|
| --------------------------- | ----------------- |
| and the contribution of the count | |||
|---|---|---|---|
| Device Name: | FRC POSTEC | ||
| 110 1 2 3 1 1 2 3 1 1 2 3 1 1 2 3 1 1 2 3 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ||
Indications For Use:
FRC Postec is intended for use by dentists to give retention for reconstruction of endontically treated teeth
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
Susan Runne
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510/k) Number 170/ 280 J 510(k) Number 10
(Optional Format 1-2-96)