(86 days)
SEAL & PROTECT™ DENTAL VARNISH is a protective sealant for exposed dentine. The Indications for Use are: (1) Reduction of abrasion and erosion of exposed cervical dentine; and (2) Treatment of hypersensitive cervical areas.
SEAL & PROTECT™ DENTAL VARNISH is a nanofilied light-curing dental varnish designed to protect exposed dentine areas, both mechanically and by way of an antimicrobial agent.
This submission describes SEAL & PROTECT™ DENTAL VARNISH, a nanofilled light-curing dental varnish. The primary claim of the device is its safety and effectiveness.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Goal) | Reported Device Performance (as demonstrated in the study) |
|---|---|
| Absence of cytotoxicity | The device was evaluated for cytotoxicity (L929). The conclusion indicates "no evidence of any hazardous effects to the patient if the product is used as directed." |
| Absence of mutagenicity | The device was evaluated for mutagenicity (Ames Test). The conclusion indicates "no evidence of any hazardous effects to the patient if the product is used as directed." |
| Safety regarding migration of constituents | "The possibility of migration of constituents occurring during the application and polymerization phase cannot be absolutely ruled out. However, in light of the low volume of material applied, the low solubility in physiological liquids and the inert properties of the polymerized synthetic matrix, the amount and type of the substances temporarily released from the product must be considered as harmless." (This is a qualitative risk assessment rather than a quantitative performance metric). |
| Equivalence to predicate devices (Prime & Bond® NT™ Universal Dental Adhesive K982394) | The submission states, "We believe that the prior use of the components of SEAL & PROTECT™ DENTAL VARNISH in legally marketed devices, the results of biocompatibility testing, and the performance data support the safety and effectiveness of SEAL & PROTECT™ DENTAL VARNISH for the indicated uses." The FDA's substantial equivalence letter confirms this, stating the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly mentioned in terms of subject or clinical data. The testing described (cytotoxicity and mutagenicity) refers to laboratory tests.
- Data Provenance: Not specified. The biocompatibility tests (L929 toxicity and Ames Test) are commonly in-vitro laboratory tests and typically do not involve human subjects or specific country data provenance in this context. They are likely conducted in a lab setting. It is not specified if the data is retrospective or prospective, but given the nature of the tests, they would be experimental.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The ground truth for the cytotoxicity and mutagenicity tests would be based on established scientific protocols and interpretation by qualified toxicologists or biologists, but specifics are absent.
4. Adjudication Method for the Test Set
This information is not provided. Adjudication methods like 2+1 or 3+1 are typical for clinical trials where multiple experts assess outcomes. For in-vitro biocompatibility tests, the interpretation typically relies on a single, qualified expert following established scientific guidelines.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission focuses on biocompatibility and general safety, and substantial equivalence to a predicate device, rather than comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This device is a dental varnish, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable.
7. The Type of Ground Truth Used
The ground truth used for the reported performance (cytotoxicity, mutagenicity, and safety assessment) is based on:
- Standardized in-vitro biocompatibility tests: L929 cell culture for cytotoxicity and Ames Test for mutagenicity, which have defined positive and negative controls and interpretation criteria.
- Expert qualitative assessment: For the migration of constituents, a qualitative assessment by DENTSPLY experts concluded the amount and type of temporarily released substances were "harmless" based on material properties and application volume.
- Predicate device equivalence: Implied safety and effectiveness grounded in the regulatory history and proven performance of the designated predicate device (Prime & Bond® NT™ Universal Dental Adhesive).
8. The Sample Size for the Training Set
N/A. This device is not an AI/ML algorithm that requires a training set. The "training" for this product would be its formulation and development based on established dental material science principles.
9. How the Ground Truth for the Training Set Was Established
N/A. As this is not an AI/ML algorithm, there is no "training set" or ground truth established for it in that context. The "ground truth" for the material's properties and intended function would have been established through extensive research and development in dental materials science.
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.