(83 days)
For use in the sealing of prepared root canals in adult or decidious teeth prior to final filling with gutta percha or other acceptable root canal filler. Used to promote healing effects and to help prevent bacterial contamination of the canal.
Endodontic Sealer
The provided text is a clearance letter from the FDA for a medical device called "Dentalis Kez Endodontic Sealer" (K971642). It states that the device is substantially equivalent to a predicate device and can be marketed. However, this document does not contain specific acceptance criteria, details of a study proving the device meets those criteria, or any information related to AI or algorithm performance.
Therefore, I cannot provide the requested information. The document is a regulatory clearance and not a study report or clinical trial summary.
To clarify, the information I cannot extract from the provided text includes:
- A table of acceptance criteria and the reported device performance: This document only states the device is "substantially equivalent" for its indications for use. It does not list specific performance metrics or acceptance criteria.
- Sample size used for the test set and the data provenance: No study details are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No study details are provided.
- Adjudication method for the test set: No study details are provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is a physical dental sealer, not an AI or imaging device, so MRMC studies are not relevant. This document does not mention any AI component.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an algorithm.
- The type of ground truth used: No study details are provided.
- The sample size for the training set: Not applicable as this is not an algorithm.
- How the ground truth for the training set was established: Not applicable as this is not an algorithm.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kyle H. Sibinovic, Ph.D. ·Agent Neodental Chemical Company, Ltd. C/O Shaldra, Incorporated 7613 Carteret Road Bethesda, Maryland 20817
JUL 2 4 1997
Re : K971642 Trade Name: Dentalis Kez Endodontic Sealer Requlatory Class: II Product Code: EMA Dated: May 2, 1997 Received: May 2, 1997
Dear Dr. Sibinovic:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations. Title 21, Parts 800 to 895. ਪ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Dr. Sibinovic
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Time A Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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510 (k) Number (if known): K971642
Device Name: Dentalis Kez Endodontic Sealer
Indications for Use; For use in the sealing of prepared root canals in adult or decidious teeth prior to final filling with gutta percha or other acceptable root canal filler. Used to promote healing effects and to help prevent bacterial contamination of the canal.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | Gerald Shipp |
| Division of Dental, infection Control, and General Hospital Devices | |
| 510(k) Number | K971642 |
| Prescription Use(Per 21 CFR801 109) | ✓ |
| OR | |
| Over-The-Counter Use(Optional For |
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Over-The-Counter Use (Optional Fomat 1-2-96)
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
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 § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.