(112 days)
HyperFil®-LV is a dual-cure, tooth shade, resin composite which is indicated for Class I, II, III, IV, and V restorations, including root surface cavities, post cementing, and core build-ups.
HyperFil®-LV is a dual-cure, highly radiopaque, flowable, bulk-fill composite restorative material suitable for direct and indirect restorations. HyperFil®-LV is light-curable to a depth of about 3-4 mm in 40 seconds with a dental curing light emitting at 430 - 480 nm with an intensity of >600 mW/cm². It will also self-cure to any depth in about 4-5 minutes at mouth temperature. HyperFil®-LV contains a combination of filling agents which give restorations constructed with HyperFil®-LV high compressive, tensile, and flexural strength. HyperFil®-LV will be packaged in single dual-chamber 5 mL syringes. The device comprises catalyst and base components, which are combined just prior to use via a mixing tip which is affixed to the dual chamber syringe.
This document, a 510(k) summary for the medical device HyperFil-LV, does not contain information related to an AI/ML device study. Instead, it describes a dental resin composite and its equivalence to a predicate device based on physical and chemical properties. Therefore, I cannot provide details on acceptance criteria, test sets, expert ground truth establishment, or clinical performance related to AI/ML as these are not present in the provided text.
The document discusses the following non-AI related aspects:
1. A table of acceptance criteria and the reported device performance:
| Property (pass/fail criteria, if applicable) | Acceptance Criteria for Predicate Device (Celerity) | Reported Device Performance (HyperFil®-LV) |
|---|---|---|
| Compressive Strength | >300 MPa | >300 MPa |
| Flexural Strength | >100 MPa | >100 MPa |
| Tensile Strength | >40 MPa | >40 MPa |
| Depth of Cure | >1 mm | >1 mm |
| Modulus of Elasticity | >10 GPa | >10 GPa |
| Radiopacity | >200% | >200% |
| Water Sorption |
§ 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.