(302 days)
All-Bond Universal SC adhesive is used for:
- Direct Restorations (e.g. resin-based composite, resin-modified glass ionomer, core build-ups)
- Indirect Restorations (e.g. metal, glass, ceramics, zirconia/alumina)
- Bonding Resin or Primer for Substrates
- Desensitization/Sealing of Tooth
- Intraoral Repair (e.g. chipped porcelain, additions to direct restorations)
All-Bond Universal SC is an auto-polymerizing adhesive with a light-curing alternative. It is designed for the dentist who prefers not to light cure the adhesive layer under indirect restorations. All-Bond Universal SC has a low film thickness (
The provided text is a 510(k) summary for a dental adhesive, "All-Bond Universal SC," indicating its substantial equivalence to a predicate device, "ACE Bond SE." The summary focuses on chemical composition, physical/mechanical properties, and biocompatibility rather than clinical performance based on a test set and ground truth in the way one might expect for an AI/CADe device. Therefore, many of the requested categories about acceptance criteria, study design for a test set, expert involvement, and ground truth are not applicable or cannot be extracted from this document, as it describes a traditional dental adhesive, not a diagnostic or AI-powered medical device.
However, I can extract the information that is present and indicate where the requested information is not available in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (All-Bond Universal SC) |
|---|---|---|
| Light-Cured | X (Present) | X (Present) |
| Auto-Polymerizing | X (Present) | X (Present) |
| Unfilled, multifunctional methacrylate resin | X (Present) | X (Present) |
| Ethanol based | X (Present) | X (Present) |
| Two component adhesive | X (Present) | X (Present) |
| Color Changes from pink to clear after cure | X (Present) | --- (Not Present) |
| Solvent Based Formulation (solvent>40% by weight) | X (Present) | X (Present) |
| Self-Etching Dental Adhesive | X (Present) | X (Present) |
| Total-Etching Dental Adhesive | X (Present) | X (Present) |
| Film Thickness | Modified technique from ISO 4049 | ` |
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.