(50 days)
Extended fissure sealing First-layer lining for class I and class II cavities Class I, II, III and V direct restorations Repair of direct and indirect restorations in combination with a suitable adhesive Splinting loosened teeth resulting from trauma or periodontal associated events
Venus Bulk Flow ONE is a light curing, radio-opaque nano-hybrid composite. The uncured dental composite is introduced into the oral cavity to be applied and cured to the tooth structure or restoration pre-treated by the dentist, thus achieving the clinical benefit.
The provided text describes the regulatory submission for the Venus Bulk Flow ONE, a dental restorative material. It focuses on demonstrating substantial equivalence to a predicate device (Venus Diamond Flow, K091635) primarily through non-clinical bench testing. There is no information regarding AI/ML device acceptance criteria or performance.
Here's the breakdown of the information requested, based on the provided text:
1. Table of acceptance criteria and the reported device performance:
| Parameter | Required Specification (Acceptance Criteria per ISO 4049:2019) | Reported Device Performance (Venus Bulk Flow ONE) |
|---|---|---|
| Sensitivity to dental OP light | > 60 s | Exceeded specification (results equal or better than predicate) |
| Depth of cure | > 1.5 mm | Achieved 4 mm (predicate device was 2 mm) |
| Flexural strength | > 80 MPa | Exceeded specification (results equal or better than predicate) |
| Water sorption | 100%-Al and SD |
§ 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.