(169 days)
DiaEtch is a 37% phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.
Blue colored gel-type substance containing 37% phosphoric acid that corrodes enamel and dentine.
The provided document describes a 510(k) premarket notification for a dental product called DIAETCH, which is a phosphoric acid etchant. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing de novo performance criteria or conducting clinical efficacy studies with human subjects.
Therefore, the acceptance criteria and study information requested in your prompt (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, effect size for human reader improvement with AI) are not applicable to this type of medical device submission. These details are typically required for AI/ML-driven devices or those requiring clinical performance data to establish safety and effectiveness.
This submission relies on non-clinical performance data to demonstrate substantial equivalence to its predicate devices (Seity 37% Phosphoric Acid Etching Gel and Acid Etchant).
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are implicitly based on demonstrating similar physical and chemical properties to the predicate devices and passing standard biocompatibility tests.
| Test | Acceptance Criteria (Implied) | DIAETCH Performance | Primary Predicate Device Performance (Seity 37% Phosphoric Acid Etching Gel) | Reference Predicate Device Performance (Acid Etchant) |
|---|---|---|---|---|
| pH | Similar to predicates | $1.4 \pm 0.2$ | 1.52 |
§ 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.