(5 days)
Etching the enamel and dentine for adhesive restorations.
DenFil™ Etchant-37 is an etching agent consists of 37% phosphoric acid formulations thickened with natural polymer. It is classified into tooth shade resin material, 21 CFFR Section 872.3690, because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration.
The provided text describes a 510(k) submission for a dental etching agent, DenFil™ Etchant-37, and focuses on demonstrating its substantial equivalence to a predicate device, K-ETCHANT GEL. This type of submission does not typically involve a clinical study with detailed acceptance criteria and performance metrics in the way a novel device might. Instead, the focus is on showing similarity to an already approved device.
Here's an analysis based on the provided information, noting where specific details are absent due to the nature of a 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from "Similarities" and "Safety/Performance") | Reported Device Performance (DenFil™ Etchant-37) |
|---|---|
| Device Characteristics (Main Material, Chemical Composition, Use Concept) | Same as predicate device (K-ETCHANT GEL). This is a qualitative assessment. |
| Mechanical Properties (pH, Adhesion, Viscosity) | Similar to predicate device (K-ETCHANT GEL). This implies values within an acceptable range, though the specific range or actual values are not reported. |
| Safety Tests (Biocompatibility) | Performed to ensure compliance with applicable International and US regulations. Specific results or acceptance limits are not detailed in this summary but would have been part of the full submission. |
| Performance Validation | Subjected to extensive validation prior to release. Specific performance metrics are not detailed, but likely confirm its ability to effectively etch enamel and dentin for adhesive restorations. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a comparison study demonstrating substantial equivalence to the predicate device, K-ETCHANT GEL (K062409).
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of a clinical trial with human subjects for performance evaluation as described. The "test set" here refers to samples of the etching agent itself (DenFil™ Etchant-37) used for characterization and comparison to the predicate device. The specific number of samples for pH, adhesion, and viscosity testing is not provided in this summary.
- Data Provenance: The tests (physical property measurements, biocompatibility) would have been performed by Vericom Co. Ltd. or its contracted labs. The data would be prospective in the sense that DenFil™ Etchant-37 was manufactured and then tested. The country of origin for the testing itself is likely South Korea, where Vericom Co. Ltd. is based.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. For a dental etching agent seeking 510(k) clearance based on substantial equivalence, "ground truth" isn't established by expert consensus on clinical outcomes in the same way it would be for a diagnostic AI device. Instead, the "truth" is based on established scientific principles for chemical composition, physical properties, and safety standards for dental materials.
- Qualifications of Experts: Not specified. Any experts involved would be material scientists, chemists, or toxicologists assessing the properties and safety of the dental material.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no human interpretation of results requiring adjudication in this type of submission. The results of the physical and chemical tests are objective measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices (e.g., medical imaging AI) to compare the performance of human readers with and without AI assistance. DenFil™ Etchant-37 is a dental material, not a diagnostic AI tool.
6. Standalone Performance Study (Algorithm Only)
- Standalone Study: No, a standalone performance study in the context of an "algorithm only" is not applicable as DenFil™ Etchant-37 is a chemical product, not a software algorithm. Its performance is evaluated through material science testing.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device is based on established scientific and engineering principles for dental materials. This includes:
- Chemical composition standards: Ensuring the phosphoric acid concentration is 37% and the thickening agent is a natural polymer as specified.
- Physical property measurements: Objective measurements of pH, adhesion strength to enamel/dentin, and viscosity.
- Biocompatibility standards: Compliance with international and US regulations for materials that come in contact with human tissue.
- Performance relative to a predicate device: The predicate device (K-ETCHANT GEL) serves as the benchmark for "acceptable" performance and safety.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. DenFil™ Etchant-37 is a manufactured chemical product, not a machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this device.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.