(57 days)
Suitable for use in non-load bearing Class I and II restorations, Class V restorations, paediatric and geriatric applications, core build-ups, root surface restorations and semipermanent fillings.
Also suitable for use as a base material for Class I and II cavities using the sandwich technique with composite restorations.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental cement called "Riva Self Cure." It states that the device is substantially equivalent to legally marketed predicate devices.
The information requested regarding acceptance criteria and study details for device performance cannot be found in this document. This letter primarily focuses on the FDA's determination of substantial equivalence based on the provided 510(k) submission, not on presenting detailed performance study results or acceptance criteria.
The 510(k) process typically involves demonstrating substantial equivalence to a predicate device, often through performance testing, but the specifics of that testing (acceptance criteria, study design, results) are contained within the full 510(k) submission, not summarized in the clearance letter itself.
Therefore, I cannot provide the requested table or answer the specific questions about the study from the provided text.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.