(171 days)
System for the restoration of cavities, also suitable for , core-build-up- and sealing applications. Conditioning of dentin and enamel and protecting of restored areas.
PhoGlass Fill is intended to be used as an insoluble filling cement for uniplanar fillings of class | III and V cavities, for primary tooth fillings, for linings of composite fillings and also for core build-ups.
PhoGlass Core is intended to be used as an insoluble core build-up cement and for underlinings of composite fillings.
PhoGlass Seal is intended to be used as an insoluble sealing cement for hypersensitivity prevention and control, for root surface protection, for fissure protection and for interroediate restorations of lesions.
PhoGlass Prime is intended to be used as a conditioner for dentin and enamel to enhance the bond between the cements and the tooth structure.
PhoGlass Protect is intended for protecting PhoGlass restorations from exposure to moisture.
PhoGlass is a system consisting of a Glass lonomer restorative dental material suitable for restorative, core build-up-, and sealing-purposes. In addition it contains a dentinel engmel conditioner and a liquid suitable for protective coatings of the restorations
The provided text K082115 is a 510(k) premarket notification for a dental material and does not contain the information requested in the prompt regarding acceptance criteria, study details, and performance metrics.
The document primarily focuses on:
- Identification of the device: PhoGlass (Fill, Core, Seal, Prime, Protect)
- Classification: Dental Cement (21CFR § 872.3275)
- Intended Use: Restoration of cavities, core build-up, sealing, conditioning, and protective coatings.
- Substantial Equivalence Claim: To legally marketed predicate devices (Fuji IX GP Extra, Fuji VII, GC Dentin Conditioner, GC Fuji Varnish).
- Regulatory information: FDA's substantial equivalence determination, regulation numbers, contact information.
Therefore, I cannot provide a table of acceptance criteria, device performance, or details about a study to prove meeting those criteria based on the provided text. The prompt asks for information that is typically found in a clinical study report or a detailed pre-clinical testing summary, none of which is present in the given 510(k) summary.
§ 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.