(89 days)
TempFlex is indicated for the fabrication of temporary crowns and bridges, inlays, onlays and veneers.
TempFlex is a two component resin based material dispensed and mixed by a cartridge/static mixing tip combination. TempFlex is compatible with light cured composites for repair and characterization.
The document describes the submission of a 510(k) premarket notification for a dental device called TempFlex. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical or performance study with defined metrics.
Instead, the submission focuses on demonstrating substantial equivalence to an existing legally marketed predicate device (Temphase) based on non-clinical test data.
Here's an attempt to structure the information based on your request, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Compared to Predicate) |
|---|---|
| Biocompatibility ISO 10993 | Meets ISO 10993 standards (demonstrates safety for intended use) |
| Working Time (Comparable to predicate) | Bench tested against Temphase |
| Setting Time (Comparable to predicate) | Bench tested against Temphase |
| Compressive Strength (Comparable to predicate) | Bench tested against Temphase |
| Diametral Strength (Comparable to predicate) | Bench tested against Temphase |
| Flexural Strength (Comparable to predicate) | Bench tested against Temphase |
| Shore D Hardness (Comparable to predicate) | Bench tested against Temphase |
Note: The document does not provide specific numerical acceptance criteria (e.g., "Working Time must be X +/- Y minutes") or the exact numerical results for TempFlex and the predicate device. It only states that these characteristics were "evaluated" and used to support substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified for any of the bench tests (Working Time, Setting Time, Compressive Strength, etc.).
- Data Provenance: The studies were non-clinical bench tests. No specific country of origin is mentioned for the data, but the company is based in California, USA. The data is implicitly retrospective in the sense that it was generated for this regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. The "test set" for this submission consists of material properties measured via bench testing, not clinical data requiring expert assessment for ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. As per point 3, this was bench testing of material properties, not clinical data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. The document explicitly states: "Clinical testing has not been conducted on this product." Therefore, no MRMC study was performed.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a dental material, not an algorithm or AI system.
7. The Type of Ground Truth Used
- For Biocompatibility: Adherence to ISO 10993 standards.
- For Performance Characteristics (Working Time, Setting Time, etc.): Comparison to the predicate device (Temphase)'s performance, as measured through standard laboratory bench tests. The predicate's established performance serves as the "ground truth" for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
- Not Applicable. This is a dental material, not a machine learning model. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As per point 8.
Summary of Device and Study:
The device, TempFlex, is a two-component resin-based material for temporary dental restorations. The study presented in the 510(k) submission is a non-clinical bench study designed to establish substantial equivalence to an existing legally marketed device (Temphase).
Substantial equivalence was demonstrated by:
- Confirming biocompatibility according to ISO 10993 standards.
- Evaluating and comparing key performance characteristics (Working Time, Setting Time, Compressive Strength, Diametral Strength, Flexural Strength, and Shore D Hardness) of TempFlex against the predicate device, Temphase, through bench testing.
No clinical testing, human reader studies, or AI/software evaluations were performed or reported in this submission. The regulatory pathway chosen relied on demonstrating that the new device's material properties and safety profile were comparable to a predicate device already on the market.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.