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Artiste SE Flowable Composite product is a self-etch, self-adhesive flowable resin composite indicated for light-cured dental restorations. Applications include:

• Self-etch base liner
• Restorations of carious lesions
• Class 1, III, and V cavity preparations
• Pit and fissure sealant.

The subject device is a light-cured self-etching, self-adhesive composite in a BisGMA-free resin formulation. The Artiste SE Flowable Composite requires no application of etchant, primer or adhesive prior to device use once the restorative site has been properly prepared. Device composition is approximately 65% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Artiste SE Flowable Composite is a barium boro-silicate glass. This filler type provides the subject device with the required strength and radiopacity features. Product is supplied in various shades either in multi-use syringe or single dose delivery systems. Product packaging includes kit or refill configuration.

The provided text does not contain detailed information about specific acceptance criteria and the results of a study designed to prove the device meets those criteria. The document is a 510(k) summary for the Artiste SE Flowable Composite, focused on establishing substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot populate the table or answer the other questions based on the provided text. The document states: "A review for safety and effectiveness was performed and found not to have been affected," which is a general statement about the review, not a detailed description of a performance study with defined acceptance criteria.

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