(66 days)
Ketac-Molar® Aplicap® is a glass ionomer cement material indicated for the following uses: (1) linings for Class I and II cavities filled with composite; (2) core build-ups; (3) fillings in deciduous teeth; (4) fillings in Class I cavities located in non-occlusal load bearing areas; (5) fillings in Class V cavities if the aesthetics are not of primary importance; and (6) temporary fillings in Class I and II cavities.
slightly modified glass ionomer cement material, referred to by the tradename Ketac-Molar Aplicap®. The reason for this modification is to provide for an improved compressive strength.
This document describes a 510(k) premarket notification for modifications to a dental cement material (Ketac-Molar Aplicap®), focusing on improved compressive strength. The request is to identify acceptance criteria and study details. However, the provided text does not contain information about acceptance criteria or a study with performance results relevant to the specified questions.
The document states: "Ketac-Molar® Aplicap® meets the requirements of relevant DIN and ISO standards for dental cement." This indicates that the product adheres to general dental cement standards, but it doesn't provide specific quantitative acceptance criteria or a study detailing device performance against those criteria in the format requested.
Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document focuses on the reason for modification (improved compressive strength) and claims substantial equivalence based on physical and technical characteristics and water-soluble fluoride content compared to predicate devices, and adherence to standards, but not a detailed study report with performance metrics.
§ 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.