(64 days)
For use to stimulate the healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectomy, or for the apexegenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha. These indications include application in: Intracanal Medicament, Apexification, Periapical Lesions, Root Resorption, Temporary Root Filling, Perforations, Underdeveloped pulpless teeth.
DIAPEX is a yellow radiopaque calcium hydroxide paste with iodoform, used as a root canal filling material. It is packaged as a 2 gm syringe. Intraoral application uses enclosed disposable intracanal tips.
This document is a 510(k) summary for the medical device "DIAPEX," a calcium/iodoform root canal treatment paste. The purpose of this summary is to demonstrate that DIAPEX is substantially equivalent to a legally marketed predicate device, Vitapex Pre-loaded dental syringe (K973667).
The document does not contain information regarding a study with specific acceptance criteria and detailed device performance metrics in the format requested. Instead, it relies on demonstrating substantial equivalence to a predicate device through a comparison of intended use, chemical composition, and mechanical/physical properties.
Therefore, many of the requested sections below cannot be populated from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The submission focuses on substantial equivalence rather than performance against pre-defined acceptance criteria from a specific study. The "reported device performance" is implied to be equivalent to the predicate device's performance.
| Criterion Type | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Intended Use | Equivalent to predicate device (Root Canal Filling Material) | DIAPEX is a Root Canal Filling Material |
| Chemical Composition | Equivalent to predicate device (Calcium Hydroxide / Iodoform Paste) | DIAPEX is a Calcium Hydroxide / Iodoform Paste |
| Mechanical/Physical Properties | Equivalent to predicate device (Yellow Radiopaque Paste) | DIAPEX is a Yellow Radiopaque Paste |
2. Sample size used for the test set and the data provenance
Not applicable. No specific test set or study with performance data is presented. The substantial equivalence argument relies on direct comparison of characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a test set is not established as no performance study is described.
4. Adjudication method for the test set
Not applicable. No test set adjudication method is described.
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 device is a treatment paste, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a treatment paste, not an algorithm.
7. The type of ground truth used
Not applicable. No performance study requiring a specific type of ground truth is described. The "ground truth" for substantial equivalence is the characteristics and intended use of the predicate device.
8. The sample size for the training set
Not applicable. No training set is relevant for a medical paste device submission based on substantial equivalence.
9. How the ground truth for the training set was established
Not applicable. No training set is relevant for a medical paste device submission.
§ 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.