(46 days)
Pulpdent Etch-Rite Royale is a 37% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin or enamel before tooth restoration. Etch-Rite Royale is dark blue for contrast with tooth enamel and easy visualization. Etch-Rite Royale is a soft gel that is easily manipulated and that rinses completely without leaving any residue.
Pulpdent Etch-Rite Royale is a 37% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin or enamel before tooth restoration. Etch-Rite Royale is a dark blue color for contrast with tooth enamel and easy visualization. Etch-Rite Royale is a soft gel that is easily applied and manipulated over tooth surfaces, does not run or flow after placement, and rinses completely without leaving any gel residue or color on the tooth.
The provided document is a 510(k) Premarket Notification for a dental product called "Pulpdent Etch-Rite Royale." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific performance acceptance criteria through a study in the same way one might for a novel AI device.
Therefore, many of the requested categories are not applicable to this document as it describes a traditional medical device (etchant gel) and not an AI/ML powered device.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
For this type of device (a phosphoric acid etchant gel), the "acceptance criteria" are primarily related to its chemical composition, physical properties (e.g., consistency, color, rinsability), and its intended use being substantially equivalent to legally marketed predicate devices. The document does not report specific quantitative performance metrics or acceptance criteria in the way an AI device might report sensitivity or specificity.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|
| Composition (37% phosphoric acid) | 37% phosphoric acid in gel form |
| Form (gel) | Gel form |
| Intended Use (etching dentin/enamel before restoration) | Used for etching dentin or enamel before tooth restoration |
| Color (for contrast and easy visualization) | Dark blue color for contrast and easy visualization |
| Consistency (soft gel, easily applied/manipulated, does not run/flow) | Soft gel that is easily applied and manipulated over tooth surfaces, does not run or flow after placement |
| Rinsability (rinses completely without residue/color) | Rinses completely without leaving any gel residue or color on the tooth |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The document does not describe a clinical or performance study with a test set. This submission relies on demonstrating substantial equivalence to predicate devices, which implies that the safety and effectiveness are established by the long history of safe use of those predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No test set or ground truth establishment by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication 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 is not an AI-powered device, and no MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. As no specific performance study is detailed, no explicit ground truth is mentioned. The safety and effectiveness are inferred from the long-term a "high benefit-to-risk ratio" and "no evidence of short-term or long-term risk or suspicion of any problems" with the predicate devices.
8. The sample size for the training set
- Not Applicable. This is not an AI-powered device requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI-powered device requiring a training set.
§ 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.