(89 days)
Interface "" is a ceramic primer/ conditioner, which allows the clinician to bond any type of ceramic (including newer high strength ceramic materials) to a tooth substrate. Interface "M when used in conjunction with a resin adhesive can be used for ceramic and ceramic to tooth repairs, as well as bonding ceramic inlays, onlays, crowns and veneers.
Interface ™ is to be used as a ceramic primer/ conditioner allowing bonding to ceramic, dentin and enamel all at the same time. With Interface "1", any dental ceramic can be repaired safely in the mouth without the use of dangerous hydrofluoric acid.
Interface™ is a ceramic primer which allows the clinician to bond any type of ceramic to a tooth substrate without the pre-application of hydrofluoric acid. Interface™ is prepared by mixing one drop of each component and then waiting 30 seconds for the materials to co-mix. The advantage of being able to mix these chemistries just prior to use, assures the clinician that the mixture is always fresh. Since both chemistries are separate prior to mixing the shelf life of the materials is very stable. In comparison, traditional hydrolyzed silane has an extremely short shelf life which can unknowingly jeopardize bond strengths once near expiration or expired.
Interface™ can be used to prime/ condition tooth structure prior to repairing a tooth to ceramic restoration. The need to acid etch the substrates prior to bonding with either phosphoric or hydrofluoric acids is not necessary. As a result this eliminates any confusion for the clinician on how to prep the restoration for successful bonding.
Interface™ can be used to bond to ceramic, dentin and enamel all at the same time.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) submission for a dental bonding adhesive named "Interface™," along with the FDA's response letter.
The submission primarily describes:
- The device name, common name, classification, and product code.
- Identification of a legally marketed predicate device (hydrolyzed silane).
- A description of the "Interface™" device, highlighting its advantages over the predicate device, particularly its ability to bond to ceramic, dentin, and enamel without the need for hydrofluoric or phosphoric acid etching.
- The FDA's letter of substantial equivalence, allowing the device to be marketed.
- Indications for Use for the "Interface™" device.
There is no mention of:
- Acceptance criteria (e.g., target performance metrics like sensitivity, specificity, accuracy, bond strength thresholds).
- Any studies conducted to demonstrate the device meets specific performance criteria.
- Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
- MRMC studies or human-in-the-loop performance.
- Information about training sets or how ground truth was established for development.
Therefore, I cannot provide the requested table and information based on the given 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.