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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:

1. 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.
2. Sample size used for the test set and the data provenance: No test set or study data are presented.
3. 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.
4. Adjudication method for the test set: Not applicable.
5. 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.
6. 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. 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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