(148 days)
Apex Universal Adhesive is a single component bonding system for:
- Direct Restorations: to seal enamel / dentin prior to restoring with light-cure or self-cure . composite material
- Indirect Restorations: bonding light-cured, self-cured or dual-cured composite cements or . glass ionomer or resin-modified glass ionomer cements
- Bonding CEREC® restorations .
- Desensitization: to treat hypersensitive and / or exposed root surfaces .
- Desensitizing crown preparations .
- Sealing preparations before placing amalgams ●
- Bonding crowns and bridges .
- Bonding in posts and cores .
- Bonding veneers .
Not Found
The provided document is a 510(k) summary for a dental adhesive (Apex Universal Adhesive) and does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
This document is primarily an FDA clearance letter and an "Indications for Use" statement. It confirms that the device has been found substantially equivalent to a legally marketed predicate device, but it does not detail the specific performance studies or acceptance criteria typically associated with medical device validation. Such information would usually be found in the performance data section of the full 510(k) submission, which is not provided here.
Therefore, I cannot provide the requested information.
§ 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.