(81 days)
Super Seal is a potassium oxalate based film forming acid resistant liner and desensitizer that is indicated for application prior to restoration of exposed dentin.
Super Seal is a potassium oxalate based film forming acid resistant liner and desensitizer.
This document is a 510(k) clearance letter from the FDA for a dental device called "Super Seal." It does not contain information about acceptance criteria or a study proving device performance in the way you've requested.
The letter states that the FDA has reviewed the 510(k) notification and determined the device to be "substantially equivalent" to legally marketed predicate devices. This means that the device is considered as safe and effective as a device already on the market, and therefore does not require extensive new clinical studies to prove its performance against specific acceptance criteria.
The "Indications For Use" section on page 3 describes what the Super Seal is intended for: "Super Seal is a potassium oxalate based film forming acid resistant liner and desensitizer that is indicated for application prior to restoration of exposed dentin."
To answer your specific questions, based only on the provided document:
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A table of acceptance criteria and the reported device performance
- Not Applicable: This document is a 510(k) clearance letter, not a study report. It does not contain specific acceptance criteria or performance data from a clinical trial or performance study. The clearance is based on substantial equivalence to a predicate device.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: This document does not describe a test set or study data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable: This document does not describe a test set or ground truth establishment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: This document does not describe a test set or adjudication.
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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
- Not Applicable: This document is for a dental liner/desensitizer, not an AI-powered diagnostic device. No MRMC study is mentioned or relevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This device is a physical dental product, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: This document does not describe a study that would require ground truth determination.
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The sample size for the training set
- Not Applicable: This document describes a 510(k) clearance based on substantial equivalence, not a machine learning model or a study with a training set.
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How the ground truth for the training set was established
- Not Applicable: As above, no training set or ground truth establishment is described.
In summary, the provided document is an FDA clearance letter for a medical device based on substantial equivalence. It is not a study report and therefore does not contain the detailed performance data, study design, or expert ground truth information you've requested. Such information would typically be found in a separate submission or study report if a novel device required extensive clinical data for approval.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 22 1998
Mr. Robert A. Cherba Operation Manager Phoenix Dental, Incorporated 3452 West Thompson Road Fenton, Michigan 48430
K983477 Re : Super Seal Trade Name: Requlatory Class: II Product Code: EJK Dated: September 29, 1998 October 2, 1998 Received:
Dear Mr. Cherba:
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 leqally 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). 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you miqht have under sections 531
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Page 2 - Mr. Cherba
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 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/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timotiy 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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1 1 Page of
K983477 510(k) Number (if known): Super Seal Device Name:_
Indications For Use:
Super Seal is a potassium oxalate based film forming acid resistant liner and desensitizer that is indicated for application prior to restoration of exposed dentin.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Supo Rume
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices ાલુક સ્પર્ 510(k) Number
Prescription Use レ (Per 21 CFR 801.109)
7
OR
Over-The-Counter Use
§ 872.3250 Calcium hydroxide cavity liner.
(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.