(43 days)
Quadrant Uni-1-Bond is a light curing, single component bonding agent for universal use in combination with adhesive restorations. Quadrant Uni-1-Bond primes and bonds in one step. Quadrant Uni-1-Bond is an ethanol-based formulation of lightactivated, adhesive resins.
Quadrant Uni-1-Bond is a light curing, single component bonding agent for universal use in combination with adhesive restorations. Quadrant Uni-1-Bond primes and bonds in one step. Quadrant Uni-1-Bond is an ethanol-based formulation of lightactivated, adhesive resins.
The provided text is a 510(k) clearance letter from the FDA for a dental bonding agent, Quadrant Uni-1-Bond. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details. This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.
Therefore, I cannot extract the requested information from the provided text.
§ 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.