(14 days)
Well-Paste™ is a biocompatible root canal sealer used for the temporary filling of root canals after endodontic surgery. Well-Paste™ can be used on its own and for vital pulpectomies in deciduous teeth.
Well-Paste™ is a temporary root canal filling material after endodontic surgery as pulp capping, pulpotomy or apexification. It contains Calcium Hydroxide and Barium Sulfate mainly, so it shows excellent radiopacity. It also has high fluidity and excellent accessibility into the root canal. Well-Paste™ is premixed paste as a non-setting material and is very stable without any solidification or separation. And it is packaged in a convenient syringe with disposable tips, a plastic holder and disposable tip cap.
This document is a 510(k) summary for a dental device, specifically a root canal filling material, and does not contain information about an AI/ML powered medical device. Therefore, it is not possible to answer the questions about acceptance criteria, study details, and AI/ML specific performance metrics as requested.
The document describes the device, "Well-Paste™", its intended use, and its substantial equivalence to a predicate device ("Metapaste"). The review focuses on material characteristics (e.g., device design, appearance, main materials, physical properties like flow, film thickness, radiopacity, solubility, and disintegration) and biocompatibility, not on algorithm performance or clinical study outcomes involving human and AI comparison.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance related to AI.
- Sample size for a test set, data provenance, or ground truth details.
- Number or qualifications of experts for ground truth.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results or effect size of AI improvement.
- Standalone algorithm performance.
- Type of ground truth used in an AI context.
- Sample size for a training set.
- How ground truth for a training set was established.
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.