(74 days)
PhoGlass Cem is intended to be used as an insoluble cement for cementing of crowns and bridges, inlays and onlays (metal and ceramic fused to metal), stainless steel crowns, orthodontic bands and used as a base or a liner.
PhoGlass Cem is a dental glass ionomer cement intended to be used as an cement for cementing of crowns and bridges, inlays and onlays (metal and ceramic fused to metal), stainless steel crowns, orthodontic bands and used as a base or a liner.
The provided document is a 510(k) premarket notification for a dental cement called PhoGlass Cem. This type of notification focuses on demonstrating substantial equivalence to a predicate device rather than on presenting extensive clinical study data and performance metrics typically associated with AI/ML-based medical devices or diagnostic tools.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set information.
Instead, the document primarily establishes:
- Device Name: PhoGlass Cem
- Intended Use: Cementing crowns and bridges, inlays and onlays (metal and ceramic fused to metal), stainless steel crowns, orthodontic bands, and as a base or liner.
- Predicate Device: Fuji I (GC Corporation)
- Substantial Equivalence Claim: PhoGlass Cem functions similarly and has the same intended use as the predicate device.
Without the specific clinical or performance study data, I cannot populate the requested table and answer the detailed questions.
Here is an explanation of why the requested information is absent from this specific type of document:
- 510(k) Premarket Notification: This regulatory pathway is used for medical devices that are substantially equivalent to a legally marketed predicate device. The primary focus is on demonstrating this equivalence in terms of intended use, technological characteristics, and safety and effectiveness, often through bench testing and comparison to the predicate, rather than through new, large-scale clinical trials that would generate the detailed performance metrics requested.
- Type of Device: A dental cement is a material, and its performance is typically evaluated through physical and chemical properties (e.g., compressive strength, film thickness, solubility) rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC, which are common for AI/ML devices.
- Content of the Document: The provided text is the "Summary of Safety and Effectiveness" and the FDA's clearance letter. Neither of these sections would typically include the detailed study methodology or comprehensive performance results that you've asked for, especially for a device of this nature undergoing a 510(k) clearance.
§ 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.