(35 days)
- Direct or indirect class 1, II, III, IV, V, and VI restorations.
- Core build-up material to replace missing tooth structure.
- Composite restorations bonded to tooth structure.
- Composite restorations bonded to metal.
- Composite restorations bonded to composite or fiber-reinforced substructure.
- Composite restorations bonded to porcelain.
The ADVENT™ system is comprised of a Dentin component and an Enamel component. ADVENT Dentin is a highly filled (78.6% w/w) composite designed for class I. II. III. IV. V. and VI restorations and composite core build-up. ADVENT™ Enamel is a highly filled composite which, like belleGlas™ Enamel, is designed for high resistance to wear and abrasion as well as good polishability. Both Dentin and Enamel components are radiopaque and polymerizable by a dual cure system (heat/light), i.e., can be light cured by conventional means or processed in a dedicated curing device that employs heat and light in a pressurized, oxygen-free nitrogen atmosphere. The ADVENT™ system is designed to be used with high quality dentin/enamel adhesive systems.
This submission pertains to the ADVENT™ dental composite system. The acceptance criteria and supporting study details are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Property) | Acceptance Criteria (Predicate) | Reported Device Performance (ADVENT™) |
|---|---|---|
| Diametral Tensile Strength (DTS) - Dentin | 63 MPa (belleGlas™ Dentin) | 65 MPa (ADVENT™ Dentin) |
| Diametral Tensile Strength (DTS) - Enamel | 57 MPa (belleGlas™ Enamel) | 55 MPa (ADVENT™ Enamel) |
| Biocompatibility (Cytotoxicity) | Non-toxic (belleGlas™ HP) | Non-toxic (ADVENT™) |
| Wear Resistance | High (belleGlas™ HP) | High (ADVENT™) |
| Tensile Strength (General) | Increased (belleGlas™ HP) | Increased (ADVENT™) |
| Compressive Strength | Increased (belleGlas™ HP) | Increased (ADVENT™) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for the Diametral Tensile Strength (DTS) tests. It refers to ISO 4049 and American Dental Association #27 for dental resin-based filling materials, which would typically define such sample sizes. The data appears to be retrospective, comparing the new device ADVENT™ with the legally marketed predicate device belleGlas™ HP, and seems to originate from internal BISCO, INC. testing. No country of origin for the specific test data is provided beyond the company's location in the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device's performance is based on standardized physical and mechanical property testing (DTS, wear resistance, strength) and biocompatibility testing, not on expert interpretations of clinical cases or images.
4. Adjudication method for the test set
Not applicable. This is not a clinical study involving human assessment of results.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on physical, mechanical, and biocompatibility properties rather than clinical outcomes assessed by multiple readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies performed (Diametral Tensile Strength and Biocompatibility (cytotoxicity)) are standalone tests of the material properties, without any human-in-the-loop component for performance evaluation.
7. The type of ground truth used
The ground truth used is based on:
- Standardized Physical and Mechanical Property Measurements: Diametral tensile strength (DTS) and general assertions of wear resistance, tensile strength, and compressive strength, likely measured per ISO 4049 and ADA #27.
- Biocompatibility Testing: Specifically, cytotoxicity, tested per ISO 10993-5.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no "training set." The device is a dental composite material.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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.