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

Direct restorations in posterior teeth (permanent and deciduous) in increments of up to 5mm, including the occlusal surface;
Class V restorations (cervical caries, root erosion, wedge-shaped defects)
Reconstructive build-up;-
Base and lining of direct restorations;
Repair of small defects of the enamel;
Repair of temporary acrylic and resin materials

Opus Bulk Fill Flow APS

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.
Repair in composite resin
Non-carious cervical lesions.
Planning of preparation walls.
Core build-up

Device Description

Opus Bulk Fill APS is a light-curing composite recommended for restorations performed in large increments. The technical characteristics of the product allow the professional to use increments of up to 5mm in the cavities, including the occlusal surface (it does not require an additional capping layer). The composite has approximately 79% of load filler (in mass). APS is the acronym for Advanced Polymerization System, and it consists of a combination of different photo initiators that interact among each other amplifying the curing capacity of light emitted from light-curing units.

Opus Bulk Fill Flow is a bulk-fill flowable light-curing composite (fluid) recommended to be used as base and lining of restorations on posterior teeth. That feature associated to its cure depth – due to the composite's translucency – allows Opus Bulk Fill Flow to be applied in increments of up to 4mm, reducing the time for restoring large cavities.

AI/ML Overview

The Opus Bulk Fill APS and Opus Bulk Fill Flow APS devices are dental restorative materials. The acceptance criteria and supporting study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (Specification) for Opus Bulk Fill APS	Reported Performance (Results) for Opus Bulk Fill APS	Acceptance Criteria (Specification) for Opus Bulk Fill Flow APS	Reported Performance (Results) for Opus Bulk Fill Flow APS
Sensitivity to environment lighting - ISO 4049	Physical homogeneity of the sample (no difference when compared to material not exposed to ambient light)	All results are within the range specified by ISO 4049.	Physical homogeneity of the sample (no difference when compared to material not exposed to ambient light)	All results are within the range specified by ISO 4049.
Depth of Cure - ISO 4049	> 1.0 mm for opaque materials and > 1.5 mm for non-opaque materials	All results are greater than the specified threshold, therefore the material is considered to be in conformity.	> 1.0 mm for opaque materials and > 1.5 mm for non-opaque materials	All results are greater than the specified threshold, therefore the material is considered to be in conformity.
Colour tone stability after radiation and water absorption - ISO 4049 and ISO 7491	No more than a small change in color, visually inspected by three observers with normal vision, comparing at 200-300mm for no more than 2 seconds, in a light chamber at Day Light - D65 mode, on a diffuse white background (90% reflectance) surrounded by a grey background (30 ± 5% diffuse reflectance).	All comparisons were carried out by three observers with normal eyesight (Tiago Vicente, Josley Habinzeureuter and Simone Brasil Carvalho), certified by a competent physician. They did not attest to any color difference in the samples analyzed. The results demonstrate that the product meets ISO 4049.	No more than a small change in color, visually inspected by three observers with normal vision, comparing at 200-300mm for no more than 2 seconds, in a light chamber at Day Light - D65 mode, on a diffuse white background (90% reflectance) surrounded by a grey background (30 ± 5% diffuse reflectance).	All comparisons were carried out by three observers with normal eyesight (Tiago Vicente, Josley Habinzeureuter and Simone Brasil Carvalho), certified by a competent physician. They did not attest to any color difference in the samples analyzed. The results demonstrate that the product meets ISO 4049.
Radiopacity - ISO 4049	Optical density/grey value for the specimen thickness (δs) should correspond to the second and third scale of the aluminum part.	The values found in the specimens are between the second and third scale of the aluminum part, proving that the material is radiolucent according to the requirements of ISO 4049.	Optical density/grey value for the specimen thickness (δs) should correspond to the second and third scale of the aluminum part.	The values found in the specimens are between the second and third scale of the aluminum part, proving that the material is radiolucent according to the requirements of ISO 4049.
Flexing Resistance - ISO 4049	≥ 80MPa	All results are greater than the specified threshold, therefore the material is considered as conformant.	≥ 50MPa	All results are greater than the specified threshold, therefore the material is considered as conformant.
Water sorption and solubility - ISO 4049	Sorption: Maximum of 40 µm/mm³; Solubility: maximum of 7.5 µm/mm³	The results demonstrate that the product complies the specification in the EN ISO 4049 Standard.	Sorption: Maximum of 40 µm/mm³; Solubility: maximum of 7.5 µm/mm³	The results demonstrate that the product complies the specification in the EN ISO 4049 Standard.
Accelerated Stability Studies	No significant chemical degradation and/or physical changes in forced storage conditions.	Considering the results observed at the end of the 274 days test period, the shelf-life of 3 years in the storage condition of 30 °C for the product can be confirmed.	No significant chemical degradation and/or physical changes in forced storage conditions.	Considering the results observed at the end of the 149 days test period, the shelf-life of 2 years in the storage condition of 27 °C for the product can be confirmed.
Evaluation Report Of Long-Term Stability (Shelf)	Verification of physical and chemical characteristics during expected shelf life to confirm expiration date and storage conditions.	Considering the results observed at the end of the 36 months of the long-term test (shelf), the shelf life of 3 years in the storage condition of 30°C for the product can be confirmed.	Verification of physical and chemical characteristics during expected shelf life to confirm expiration date and storage conditions.	We don't have any conclusive data about shelf life yet. At the moment we are using the estimated shelf life in 2 years in the storage condition of 27 ° C, based on no accelerated stability test.
Fluoride release	(Specification not explicitly stated, but implied to be within acceptable limits for dental materials as it's an evaluation of the rate)	The results of the fluoride release assay demonstrate no release of fluoride ions.	(Not applicable/not tested for Flow APS in the provided document)	(Not applicable/not tested for Flow APS in the provided document)
Intensity and wavelength for photocuring	The product should demonstrate the ability to polymerize with different wavelengths and power densities from photopolymerizers.	The test results demonstrate the ability of polymerization resin with differencing light devices.	(Not applicable/not tested for Flow APS in the provided document)	(Not applicable/not tested for Flow APS in the provided document)
Filler particle size distribution (microns)	Grain size analysis and optical characteristics within specifications.	The test results demonstrate the microns within the specifications.	Grain size analysis and optical characteristics within specifications.	The test results demonstrate the microns within the specifications.

2. Sample size used for the test set and the data provenance:

The provided document does not explicitly state the numerical sample size for each specific test, nor does it detail the provenance (e.g., country of origin, retrospective/prospective) of the materials tested. The tests were "pre-clinical tests" performed in a laboratory setting to evaluate physical and chemical properties.

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

For the Colour tone stability after radiation and water absorption test, three observers were used. Their qualifications are stated as: "normal eyesight (Tiago Vicente, Josley Habinzeureuter and Simone Brasil Carvalho), certified by a competent physician."

For other physical and chemical tests, "ground truth" is established by the specifications defined in the ISO standards (ISO 4049, ISO 7491), rather than expert consensus on a specific test set in the same manner as, for example, image interpretation.

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

For the Colour tone stability test, the adjudication method was essentially a unanimous consensus of the three observers who "did not attest to any color difference in the samples analyzed." For other tests, the results are quantitative measurements compared against predefined ISO standard thresholds, not requiring expert adjudication in that context.

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:

This is not applicable. The devices (Opus Bulk Fill APS and Opus Bulk Fill Flow APS) are dental restorative materials, not AI-assisted diagnostic or assistive devices. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance was not performed.

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

This is not applicable. The devices are physical dental materials, not algorithms.

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

The "ground truth" for evaluating the performance of these dental restorative materials is primarily based on international recognized standards (ISO 4049, ISO 10993-1, ISO 7491) which define objective physical and chemical properties and their acceptable ranges. For the color stability test, a form of expert consensus (three certified observers with normal vision) was used to visually confirm the absence of color change.

8. The sample size for the training set:

This is not applicable. These are physical materials, not machine learning algorithms. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established:
This is not applicable as there is no training set for a physical dental material.

Summary

Regulation Number and Section

§ 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.