FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Opallis (Sculptable version)

The composite is suitable for use in permanent and deciduous teeth:
Direct restorations in anterior and posterior teeth Classes I, II, III, IV, V and VI.
Direct veneers with composites.
Cementation of tooth fragments.
Core build-ups.
Teeth splinting.
Diastema closing or reduction.
Modification of teeth's shape (e.g .: conoid teeth).
Porcelain/composite repairs.

Opallis Flow (Flowable version)

Base/lining underneath direct restorations.
Small, non-occlusal stress-bearing class I restorations according to minimally invasive filling therapy
Pit and fissure sealant.
Tunnel-type preparation.
Repair of enamel defects.
Bonding of tooth fragments.
Repairs in composite resin.
Non-carious cervical lesions.
Planning of preparation walls.

Device Description

Opallis is a, radiopaque, light-curing composite resin with fluorescent and opalescent properties. It is an aesthetic restorative material used for restorations of anterior and posterior teeth.

Opallis Flow is a light-curing composite resin used for the restoration of slightly invasive preparations, pit and fissure sealant, base/lining underneath direct restorations, in tunnel-type preparations, radiopaque lining of cavities, repairs of enamel defects, restorations of primary teeth, repairs in composite resin, bonding of tooth fragments, class I, III and V restorations, non-carious cervical lesions. Opallis Flow can be used separately or with Opallis composites.

AI/ML Overview

The provided text describes the acceptance criteria and performance data for two dental composite resins, Opallis and Opallis Flow, to demonstrate their substantial equivalence to predicate devices for FDA 510(k) clearance.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance (Opallis and Opallis Flow):

Test	Acceptance Criteria (Specification)	Opallis Reported Performance	Opallis Flow Reported Performance
Sensitivity to ambient lighting	Physical homogeneity of the sample after exposure to ambient light (compared to unexposed material). Must show no difference. (ISO 4049)	All results are within the range specified by ISO 4049 (material considered physically homogeneous).	All results are within the range specified by ISO 4049 (material considered physically homogeneous).
Depth of Cure	> 1.0 mm for opaque materials; > 1.5 mm for non-opaque materials. (ISO 4049)	Opaque shades: 2.99 mm
Non-opaque shades: 2.84 mm

All results > specified threshold. | Opaque shades: 2.97 mm
Non-opaque shades: 3.01 mm

All results > specified threshold. |
| Color tone stability | No more than a small change in color, as determined by visual inspection by three observers with normal vision in a D65 light chamber, comparing specimen on a diffuse white background against a gray background. (ISO 4049 and ISO 7491) | All comparisons carried out by three observers with normal eyesight; no color difference attested. | All comparisons carried out by three observers with normal eyesight; no color difference attested. |
| Radiopacity | Values found in specimens demonstrating they are radiolucent, typically between the second and third scale of the aluminum part. (ISO 4049) | 2.46 mm. Values found are between the second and third scale of the aluminum part. | 2.49 mm. Values found are between the second and third scale of the aluminum part. |
| Flexural Strength | ≥ 80 MPa (EN ISO 4049) | 93.38 MPa. All results > specified threshold. | 137.80 MPa. All results > specified threshold. |
| Water Sorption | Maximum of 40 µg/mm³ (ISO 4049) | 28.93 µg/mm³. Complies with specification. | 27.92 µg/mm³. Complies with specification. |
| Solubility | Maximum of 7.5 µg/mm³ (ISO 4049) | 5.53 µg/mm³. Complies with specification. | 5.46 µg/mm³. Complies with specification. |
| Shelf Life (Accelerated Stability) | Confirmed shelf-life based on accelerated degradation studies (e.g., 3 years at 30°C). | 3 years at 30°C confirmed based on 274 days test. | 3 years at 30°C confirmed based on 274 days test. |
| Shelf Life (Long-Term Stability) | Confirmed shelf-life based on physical and chemical characteristics during expected shelf life (e.g., 3 years at 30°C). | 3 years at 30°C confirmed based on 36 months test. | 3 years at 30°C confirmed based on 36 months test. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: The document does not explicitly state the specific numerical sample size (e.g., number of specimens tested for each physical property). It refers to "the samples" for various tests.
Data Provenance: The tests are non-clinical and performed by the manufacturer, Dentscare LTDA, which is based in Joinville, Santa Catarina, Brazil. The studies appear to be prospective, laboratory-based tests comparing the manufactured devices against ISO standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

For the Color tone stability test: "three observers with normal eyesight, certified by a competent physician" were used for visual inspection. No further qualifications (e.g., years of experience, specific medical specialty) are provided beyond "normal vision" and "certified by a competent physician."
For other physical property tests (e.g., flexural strength, depth of cure), the "ground truth" is established by adherence to International Standards (ISO 4049) rather than expert consensus on individual outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

For Color tone stability, it states: "All comparisons were carried out by three observers... They did not attest to any color difference in the samples analyzed." This implies a form of consensus or 3/3 agreement among these observers. There is no explicit mention of an adjudication process like "2+1" if there were disagreement, but the stated outcome implies unanimous agreement.
For other tests, adherence to the numerical specifications of ISO standards serves as the "adjudication."

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:

No MRMC comparative effectiveness study was done. This device is a dental restorative material (composite resin), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical dental material, not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For physical and chemical properties, the ground truth is based on International Standards specifications (specifically ISO 4049) and objective measurements compared against these predefined ranges.
For biocompatibility, the ground truth is established through laboratory in-vitro and in-vivo tests (e.g., cytotoxicity, sensitization, irritation, genotoxicity, implantation) conducted according to ISO 10993 standards. Additionally, the pre-existence of similar products on the market ("long term (10 years) the subject devices are in the market with no chronic toxicity reported") and comparison to predicates with more complex formulations (Vittra APS) informs the biocompatibility conclusions.
For Color tone stability, a form of expert visual consensus (3 certified observers) is used against a control.

8. The sample size for the training set:

Not applicable. This is a physical dental material. The "training" for such devices would be the manufacturing process development and quality control, not a data-driven training set in the AI sense.

9. How the ground truth for the training set was established:

Not applicable, as there is no "training set" in the context of an AI/algorithm where ground truth is established. The manufacturing and material specifications are developed and validated against industry standards and internal quality controls.

§ 872.3690 Tooth shade resin material.