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Point 4 Flowable 2 is a low viscosity light cure hybrid resin restorative suitable for Class III, Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.

Point 4 Flowable 2 is a low viscosity light cure hybrid resin restorative suitable for Class III, Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.

This document is a 510(k) premarket notification for a dental restorative material, Point 4 Flowable 2. It does not contain any information about acceptance criteria, device performance, a study, or any of the other specific items requested in your prompt (e.g., sample sizes, expert qualifications, MRMC studies, ground truth details).

The document primarily focuses on:

• Device Name: Point 4 Flowable 2
• Submitter: Sybron Dental Specialties, Inc.
• Device Description: Low viscosity light cure hybrid resin restorative for various dental applications (Class III, IV, V restorations, enamel/porcelain repair, pit and fissure sealant, etc.).
• Intended Use: Same as device description.
• Substantial Equivalence: Claimed to the predicate device "Point 4 Flowable" from Kerr Corporation. The FDA's letter confirms this substantial equivalence.
• Regulatory Information: Classification Name (Tooth Shade Resin Material, 21 CFR § 872.3690), Regulatory Class (Class II).

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and study details because that information is not present in the provided text.

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