(94 days)
Pulpdent OX-OUT is a tinted, glycerine and polyethylene glycol based gel used to block oxygen from the surface of anaerobic setting, resin-type dental restorative materials. Pulpdent OX-OUT prevents the formation of an oxygen inhibited layer at the margins of a restoration. It also contains a polymerization accelerant to improve setting.
Pulpdent OX-OUT is indicated during cementation of metal bridges, crowns and inlays/onlays, cementation of silanated porcelain and cured composite crowns or inlays/onlays, cementation of preformed or cast posts and cores, and for bonded amalgam restorations.
Pulpdent OX-OUT is a tinted, glycerine and polyethylene glycol based gel used to block oxygen from the surface of anaerobic setting, resin-type dental restorative materials. Pulpdent OX-OUT prevents the formation of an oxygen inhibited layer at the margins of a restoration. It also contains a polymerization accelerant to improve setting.
I am sorry, but based on the provided text, there is no acceptance criteria or study information that describes the device's performance in a quantitative manner. The document is a 510(k) premarket notification for a dental product called PULPDENT OX-OUT.
Here's what the document indicates:
- Substantial Equivalence: The FDA's decision is based on the device being "substantially equivalent" to legally marketed predicate devices (Ultradent DeOx and Panavia Oxyguard II) in composition and intended use.
- Safety and Effectiveness: The document refers to "Exhibit 6" for a "Reality article concerning the effectiveness of these types of products" and "technical sheets which detail the typical safe applications and FDA status of the two major components." However, these exhibits are not provided in the given text. Without them, it's impossible to
determine any specific performance criteria or study data. - Purpose of the Device: Pulpdent OX-OUT is a gel used to block oxygen from the surface of anaerobic setting, resin-type dental restorative materials to prevent an oxygen-inhibited layer and contains a polymerization accelerant.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study to prove they are met because that information is not present in the provided excerpts.
§ 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.