(38 days)
Bonding between dentin/enamel and composite filling materials Bonding between dentin/enamel and compomer filling matcrials Bonding mediator for fissure sealing Desensitization of hypersensitive arcas of tecth
Adper Prompt is classified as Resin Tooth Bond Agent ( 21 C.F.R. § 872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials (compomer amd composite restorative material). Additionally, as recent results show, Adper Prompt can be used to seal dentinal tubules of exposed dentin surfaces to prevent from dentinal hypersensitivity.
The provided text is a 510(k) summary for the device "Adper Prompt," a resin tooth bond agent. The submission is seeking clearance for a new indication for use: "to seal dentinal tubules of exposed dentin surfaces to prevent from dentinal hypersensitivity."
Unfortunately, the document does not contain the specific acceptance criteria or the detailed study results needed to complete the requested table and answer many of the questions. The text only states that "Performance and comparative testing of Adper Prompt has been carried out" and "The results suggest that Adper Prompt is a suitable agent to reduce fluid movement and to prevent from dentinal hypersensitivity." It also mentions that "Performance data for Adper Prompt as a dental bonding agent are, therefore, not subject of this 510(k) submission" as the chemical composition remained unchanged from a previous 510(k) clearance.
Therefore, I can only provide an incomplete response based on the information given.
Acceptance Criteria and Device Performance Study (Incomplete)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., % reduction in fluid movement, score on hypersensitivity scale) | Reported Device Performance |
|---|---|
| Not specified in the provided document. | "suitable agent to reduce fluid movement and to prevent from dentinal hypersensitivity." |
2. Sample size used for the test set and data provenance
- Sample Size (Test Set): Not specified in the provided document.
- Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and their qualifications
- Not specified in the provided document, as the study details are not present.
4. Adjudication method for the test set
- Not specified in the provided document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
- Not specified in the provided document. The submission mentions "comparative testing" but does not describe an MRMC study or its effect size.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable/Not specified. This device is a dental material, not an algorithm.
7. The type of ground truth used
- Not specified in the provided document. Given the indication, potential ground truths could involve measured fluid movement, patient-reported hypersensitivity scores, or expert clinical assessment; however, none are explicitly stated.
8. The sample size for the training set
- Not applicable/Not specified. There is no mention of a "training set" as this is a dental material, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable/Not specified.
Summary of Missing Information:
The provided 510(k) summary confirms that performance and comparative testing was conducted for the new indication of "desensitization of hypersensitive areas of teeth" (preventing dentinal hypersensitivity by sealing dentinal tubules). However, it does not include the detailed results, methodology, sample sizes, or specific acceptance criteria of these studies. It only provides a high-level conclusion that the device is "suitable." This level of detail would typically be found within the full 510(k) submission, not just the publicly available summary letter.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.