(45 days)
A light-cured, flowable composite, for use as a tooth restorative in all class cavities (I, II, III, IV and V). It is especially suitable for use in non-stress bearing class I and III restorations and for class V lesions. It may be used as a liner in all class cavity preparations, and as a pit and fissure sealant or as a composite luting resin. The material is well-suited as an undercut block-out material in cavity preparations. It may be used with all currently available dentin bonding systems.
EPIC-FLO is a light-cured, flowable composite, for use as a tooth restorative in all class cavities (I, II, III, IV and V). It is especially suitable for use in non-stress bearing class I and III restorations and for class V lesions. It may be used as a liner in all class cavity preparations, and as a pit and fissure sealant or as a composite luting resin. The material is well-suited as an undercut block-out material in cavity preparations. It may be used with all currently available dentin bonding systems.
The provided document, K973976, is a 510(k) summary for a dental device, EPIC-FLO (a flowable composite resin). It describes the device's intended use and its substantial equivalence to predicate devices. However, this document does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert adjudication as requested in your prompt.
The document is a regulatory submission for premarket notification, aiming to demonstrate substantial equivalence to existing devices. It focuses on:
- Device Identification: Trade name, common name, classification name.
- Submitter Information: Company and contact details.
- Indications for Use: What the device is intended for.
- Equivalence: Listing of predicate devices.
- Regulatory Status: FDA's letter confirming clearance based on substantial equivalence.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets those criteria because the provided text does not contain this information.
To properly answer your request, I would need a section of the document that details:
- Specific performance metrics (e.g., bond strength, wear resistance, dimensional stability).
- Quantitative thresholds for these metrics (acceptance criteria).
- Details of experimental studies conducted to measure these metrics.
- Information on study design, sample sizes, and how results were analyzed.
§ 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.