Search Results

• Class I, Class II, Class III and Class V restorations .
• Non-bearing Class I and Class II restorations in permanent teeth .
• Intermediate restoration for heavy stress situations in Class I and Class II . cavities
• Core build up .
• Liner .

Vitro Molar is a condensable, chemically activated glass ionomer cement, used in restorations of posterior teeth; it is radiopaque and offers good esthetic properties, easy manipulation, fast curing and it can be easily sculpted. It hardens via an acid/base reaction. Vitro Molar is also highly resistant to compression and bending, and has a hard, low-abrasive surface. It is ideal to be used in the atraumatic restorative treatment (ART) technique. Vitro Molar is for permanent cementation.

The provided text is a 510(k) summary for a dental cement called Vitro Molar. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving device performance against such criteria for an AI/ML powered device.

The document explicitly states: "Based on the information provided in this premarket notification, we can conclude that Vitro Molar is as safe and effective as the predicated devices." This indicates that the claim of safety and effectiveness for Vitro Molar is based on its similarity to existing, legally marketed predicate devices, not on a novel study demonstrating performance against specific acceptance criteria. This is a common approach for 510(k) submissions for conventional medical devices.

Therefore, I cannot provide the requested table or answer the specific questions related to acceptance criteria and performance studies. The information simply isn't present in the provided text.

Ask a specific question about this device