(389 days)
For the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, taking an impression, cementation and cavity preparation.
GingiDent gingival retraction paste is an astringent formulated to provide gingival retraction and hemostasis. GingiDent gingival retraction paste contains Aluminum Chloride and is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures. This product is a blue-green paste developed exclusively for transient surgically invasive use in the oral cavity. The paste contains Aluminum Chloride in a water-based clay inert carrier.
This document describes the premarket notification (510(k)) for the GingiDent Gingival Retraction Paste. The submission primarily relies on non-clinical bench testing and comparison to predicate devices, rather than a clinical study involving human subjects. Therefore, many of the requested categories related to clinical study design and outcomes (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable in this context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria (Bench Test Results) and Reported Device Performance:
| Test | Acceptance Criteria (Implied by Predicate Range) | GingiDent (Subject Device) Performance | Predicate Device 1 (Expa-syl) Performance | Predicate Device 2 (Traxodent) Performance |
|---|---|---|---|---|
| Aluminum Chloride Hexahydrate | Within range of predicates (15.80% - 21.76%) | 16.42% | 15.80% | 21.76% |
| pH | Within range of predicates (2.99 - 3.47) | 3.22 | 3.47 | 2.99 |
| Viscosity (cP) | Not explicitly defined, but between predicates | 995,000 | >1 million | 763,000 |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The testing described is bench testing of the product itself, not a clinical test set with human subjects.
- Data Provenance: Not applicable for a clinical test set. The data originates from laboratory bench testing conducted by the manufacturer, Pac-dent International, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was bench testing, not a clinical study requiring expert ground truth for patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This was bench testing.
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:
- No. This device is a gingival retraction paste, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical dental paste, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable to a clinical test set. For the bench tests, the "ground truth" was established by standard laboratory measurement techniques for pH, viscosity, and chemical concentration.
8. The sample size for the training set:
- Not applicable. This is not a machine learning device; therefore, there is no training set in the context of AI/ML.
9. How the ground truth for the training set was established:
- Not applicable.
Additional Information from the Document:
- Biocompatibility Tests: Performed in accordance with ISO 10993, including skin sensitivity and oral mucosa irritation tests in hamsters. Results showed no evidence of causing skin sensitization or oral mucosa irritation.
- Stability Tests: Accelerated stability testing was conducted at 50 °C and 60 °C, evaluating AlCl3-6H2O concentration, pH value, extrusion force, and weight loss. Estimated shelf life for room temperature storage is 2.8 years.
- Clinical Performance Test: "No clinical testing was provided." The submission relies solely on non-clinical (bench) testing and comparison to legally marketed predicate devices to establish substantial equivalence.
- Conclusion: The manufacturer concluded that GingiDent Gingival Retraction Paste is substantially equivalent to the identified predicate devices based on non-clinical performance testing. The FDA concurred with this determination for the purpose of market authorization.
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