(35 days)
SternOmega Temporary Cement Automix NE is indicated for use as a temporary cement for attaching all types of temporaries, e.g. temporary crowns, bridges, and inlays.
The SternOmega Temporary Cement Automix NE is an auto-mixing, non-eugenol cement indicated for the temporary bonding of crowns, bridges and inlays.
The Sterngold ImplaMed Abbreviated 510(k) Premarket Notification for the SternOmega Temporary Cement Automix NE does not contain information regarding acceptance criteria or a study proving the device meets said criteria.
The document explicitly states:
"Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the Temporary Cement Automix NE are equivalent to those of the predicate device."
Therefore, I cannot provide a response to your numbered points as the requested information is absent from the provided text. The submission relies solely on demonstrating substantial equivalence to a predicate device (TempoCem NE) based on design and material characteristics, rather than presenting new performance or safety study data.
§ 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.