(1 days)
•Temporary restorations
•Splinting between implant copings for impressions to resist impression material distortion
•To provide structure for isolation clamping and to act as a barrier for endodontic irrigants
• Bite ramps and temporary occlusal buildups during orthodontics
J-Temp temporary resin is a flowable resin material designed to be durable enough to stay in place after being applied. It is delivered via syringe and light cured.
This document does not contain information about acceptance criteria and study details for device performance. It is an FDA 510(k) premarket notification for a dental resin material named "J-Temp", primarily focusing on its substantial equivalence to a predicate device ("Clip Flow" by Voco).
While a table comparing technological characteristics is provided, it outlines similarities and differences between the new device and predicate devices in terms of intended use, composition, physical properties, etc. However, this table does not include:
- Specific acceptance criteria (e.g., numerical thresholds for performance metrics).
- Reported device performance against such criteria.
- Details about a study designed to prove the device meets acceptance criteria, including sample sizes, ground truth establishment, expert involvement, or comparative effectiveness.
The document states that the device "successfully passed all verification and validation testing," but it does not provide any specifics about these tests, the acceptance criteria used, or the results obtained.
Therefore, I cannot provide the requested information from the given text.
§ 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.