(189 days)
DENT-TEMP™ ACRYLIC is a self-curing system. It is available in three Vita-Shades. A-1, A-2, A-3.5. made out of Methacrylate Polymer Powder and DENT-TEMPTM LIQUID used with powders, made out of Memhylmethacrylate Monomer. DENT-TEMP™ ACRYLIC System is recommended for use in Restorative Dentistry. Whenever making of temporary crown and bridge restoration is required, this most durable, fast setting and easy to trim and polish, polymer system can be used.
DENT-TEMP™ ACRYLIC is a self-curing system. It is available in three Vita-Shades. A-1, A-2, A-3.5. made out of Methacrylate Polymer Powder and DENT-TEMPTM LIQUID used with powders, made out of Memhylmethacrylate Monomer.
The provided document is a 510(k) premarket notification letter from the FDA for a device called "Dent-Temp Acrylic." This type of document does not typically contain acceptance criteria or detailed study results in the way medical device effectiveness or diagnostic performance is usually presented.
The letter explicitly states: "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."
This means the device's acceptance was based on substantial equivalence to a predicate device, not on specific performance criteria demonstrated through a detailed clinical or standalone study as would be required for a novel device or one requiring a PMA.
Therefore, the following information cannot be extracted from this document:
- A table of acceptance criteria and the reported device performance: This document does not specify performance acceptance criteria or report performance metrics for the Dent-Temp Acrylic device.
- Sample size used for the test set and the data provenance: No test set or study data are presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific test set with ground truth is discussed.
- Adjudication method for the test set: Not applicable.
- 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 acrylic, not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of available information regarding acceptance:
- Device Name: DENT-TEMP™ ACRYLIC
- Regulatory Class: II
- Product Code: EBG
- Acceptance basis: Substantial Equivalence to legally marketed predicate devices.
- Indications for Use: DENT-TEMP™ ACRYLIC System is recommended for use in Restorative Dentistry. Whenever making of temporary crown and bridge restoration is required, this most durable, fast setting and easy to trim and polish, polymer system can be used. It is a self-curing system made of Methacrylate Polymer Powder and Memhylmethacrylate Monomer, available in three Vita-Shades (A-1, A-2, A-3.5).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 1997
Mr. Jashan Seth Executive Vice-President Health-Dent International, Incorporated 122-A Kirkland Circle Oswego, Illinois 60543
Re : K972198 Dent-Temp Acrylic Trade Name: Requlatory Class: II Product Code: EBG Dated: October 31, 1997 November 6, 1997 Received:
Dear Mr. Seth:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 requlation 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
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Page 2 - Mr. Seth
not affect any obligation you might have under sections 531 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 beqin 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 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 qeneral 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;
Timothy A. Ulatowski
My A. Ulatowski Timot 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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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 1997
Mr. Jashan Seth Executive Vice-President Health-Dent International, Incorporated 122-A Kirkland Circle Oswego, Illinois 60543
Re : K972198 Dent-Temp Acrylic Trade Name: Requlatory Class: II Product Code: EBG Dated: October 31, 1997 November 6, 1997 Received:
Dear Mr. Seth:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 requlation 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
{3}------------------------------------------------
Page 2 - Mr. Seth
not affect any obligation you might have under sections 531 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 beqin 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 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 qeneral 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;
Timothy A. Ulatowski
My A. Ulatowski Timot 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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Page 1 of 1
510 (k) Number (if known): K 972198
Device Name: DENT-TEMP™ ACRYLIC
Indications For Use:
DENT-TEMP™ ACRYLIC is a self-curing system. It is available in three Vita-Shades. A-1, A-2, A-3.5. made out of Methacrylate Polymer Powder and DENT-TEMPTM LIQUID used with powders, made out of Memhylmethacrylate Monomer.
DENT-TEMP™ ACRYLIC System is recommended for use in Restorative Dentistry. Whenever making of temporary crown and bridge restoration is required, this most durable, fast setting and easy to trim and polish, polymer system can be used.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Susan Punno | ||||
|---|---|---|---|---|
| (Division Sign-Off) | ||||
| Division of Dental, Infection Control, and General Hospital Devices | ||||
| 510(k) Number | R972198 | |||
| Prescription Use | OR | Over-The-Counter Use | No | |
| (Per 21 CFR 801.109) | ||||
| (Optional Format 1-2-96) |
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.