(72 days)
TESCERAFLO is a dual-cure (heat/light) composite designed to be used for direct or indirect restorations. Its physical properties are similar to the predicate device and uses are identical.
Indications For Use:
- l. Esthetic restorative material for Class III, IV, and V.
- Conservative Class I and Class II not involving opposing occlusal contact for 2. direct or indirect use.
- Direct Esthetic veneer restorative for masking stains and developmental 3. anomalies.
- Pit and fissure sealant. 4.
- న్. Core buildup material to replace missing tooth structure.
- Direct cement/luting agent and dental liner. 6.
- Indirect cement for use with reinforcement materials to fabricate crowns and 7. bridges.
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- Composite/porcelain repair material.
TESCERAFLO is a dual-cured (light/heat), moderately filled (60% by weight) low modulus flowable composite. It can be light cured by conventional means or processed in a dedicated curing device such as TESCERA ATL that employs heat and light in an oxygen-free environment. It is supplied in a syringe.
The provided text describes a 510(k) submission for a dental composite restorative material named TESCERAFLO. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, NTL-FLOW. Since this is a submission for a medical device and not an AI/ML algorithm, most of the requested information regarding AI performance criteria and studies is not applicable.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
The core of the submission is to demonstrate "substantial equivalence" of TESCERAFLO to the predicate device, NTL-FLOW. The acceptance criteria are implicitly that the new device shares the same intended use, fundamental technological characteristics, and similar mechanical/physical properties as the predicate device, and is found to be non-toxic.
| Acceptance Criteria / Comparison Point | Reported Device Performance (TESCERAFLO) |
|---|---|
| Intended Use | Flowable composite; for direct or indirect restorations. |
| Chemical Composition | Dual-cured (light/heat) barium glass and silica filled (60%), dimethacrylate composite. |
| Mechanical/Physical Properties | Relatively low viscosity, syringable composite. Physical properties are similar to the predicate device. |
| Biocompatibility | Found to be non-toxic. |
The document states: "Side by side comparisons of TESCERAFLO to the predicate device NTL-FLOW clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices." It further concludes, "It is concluded that the information supplied in this submission has proven the safety and efficacy of TESCERAFLO."
Study Information (Not Applicable for AI/ML device)
The submission is for a material (composite restorative), not an AI/ML diagnostic or assistive device. Therefore, the following information is not applicable and not found in the provided text:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a material science submission, not an AI/ML and human reading performance study.
- 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. "Ground truth" in this context would relate to material properties, likely measured by standardized lab tests, not expert human assessment of images.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For material properties, the "ground truth" would be established through laboratory testing following recognized standards for dental materials (e.g., ISO standards for composite resins) to measure properties like strength, viscosity, cure depth, etc. The document does not specify the exact type of tests or standards used, only that "significant performance characteristics" were compared.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
In summary, the provided document focuses on demonstrating the substantial equivalence of a dental material (TESCERAFLO) to a predicate device based on its intended use, properties, and biocompatibility, rather than evaluating an AI/ML algorithm's performance.
§ 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.