(81 days)
GDLS is a light-cured micro-filled radiopaque composite resin for the restoration of both anterior and posterior teeth. GDLS-200 consists of two delivery systems, Unitip (capsules for single dose) and Syringes. The GDLS-20() systems is available in a variety of shades.
GDLS-200 is a light-cured micro-filled radiopaque composite resin for the restoration of both anterior and posterior teeth. GDLS-200 consists of two delivery systems, Unitip (capsules for single dose) and Syringes. The GDLS-20() systems is available in a variety of shades.
The provided document is an FDA 510(k) clearance letter for a dental device (GDLS-200) and an "Indications for Use" statement. It does NOT contain information about acceptance criteria, study details, or device performance metrics as requested in the prompt.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document only confirms that the FDA found the device substantially equivalent to a predicate device for its indicated uses.
§ 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.