(52 days)
PULPDENT CALCIUM HYDROXIDE PREPARATION is a biocompatible polydimethylsiloxanebased root canal sealer used for the temporary and permanent filling of root canals after endodontic surgery. PULPDENT CALCIUM HYDROXIDE PREPARATION can be used on its own, in conjunction with Gutta Percha and for vital pulpdectomies in deciduous teeth.
PULPDENT CALCIUM HYDROXIDE PREPARATION is a biocompatible polydimethylsiloxane-based root canal sealer used for the temporary and permanent filling of root canals after endodontic surgery. PULPDENT CALCIUM HYDROXIDE PREPARATION can be used on its own, in conjunction with Gutta Percha and for vital pulpectomies in deciduous teeth.
This document is a 510(k) premarket notification for a dental device, the "PULPDENT CALCIUM HYDROXIDE PREPARATION." The review of this document confirms that it does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria through testing.
Instead, this SSED (Summary of Safety and Effectiveness Data) relies on the concept of substantial equivalence to predicate devices. It states that the device is "substantially equivalent in design, composition and intended use" to existing, legally marketed predicate devices. The safety and effectiveness are supported by:
- General usage of predicate products: "General usage of the predicate products over about 5 years indicates a high benefit-to-risk ratio."
- Lack of reported issues with predicate devices: "There is no evidence of short-term or long-term risk or suspicion of any problems."
- Existing 510(k) approvals for predicate devices: The predicate products have already received 510(k) Premarket approval.
- References to clinical literature: Several references are provided, which appear to discuss the use of iodoform paste and calcium hydroxide in endodontic procedures, likely supporting the concept of using such materials, rather than directly evaluating the specific performance of this device.
Therefore, since no specific performance study was conducted for this device as part of this 510(k) submission, the requested information elements cannot be extracted from the provided text. The device's clearance is based on its similarity to already approved devices, not on new performance data demonstrating its adherence to specific acceptance criteria.
Response regarding Acceptance Criteria and Study:
The provided document, a 510(k) Summary of Safety and Effectiveness Data for the "PULPDENT CALCIUM HYDROXIDE PREPARATION," does not contain information about specific acceptance criteria or a study designed to prove the device meets these criteria.
Instead, the device's clearance is based on the principle of substantial equivalence to predicate devices. The rationale for safety and effectiveness is derived from the established history and prior approvals of those predicate devices, rather than new performance data for the subject device against defined acceptance criteria.
Therefore, the following information cannot be provided from the given document:
- A table of acceptance criteria and the reported device performance: Not available.
- Sample sized used for the test set and the data provenance: Not applicable, as no dedicated test set for performance evaluation of this specific device is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 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 is not an AI/imaging device).
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.