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Carboxylate Cem: For temporary or permanent cementation of crowns and bridges on non-vital teeth where retention is of primary concern. Also for use as a temporary filling material.

Phosphate Cem: For permanent cementation of crowns and bridges on non-vital teeth where the use of conventional Zinc phosphate cernents is judged appropriate.

Zinc Oxide Cem consist of two different cements:

Carboxylate Cem consists of a polyacrylic/water contairing liquid and a zinc oxide/magnesiumoxide containing powder.

Phosphate Cem consists of a phosphoric acid/water containing liquid and a zinc oxide/magnesiumoxide containing powder.

This 510(k) premarket notification describes two dental cements, Carboxylate Cem and Phosphate Cem, and claims substantial equivalence to previously marketed devices. This submission does not contain information about acceptance criteria or a study proving device performance against such criteria because it relies on substantial equivalence to predicate devices, rather than novel performance claims from a new study.

Therefore, I cannot provide the requested information as it is not present in the provided text.

Based on the summary of safety and effectiveness, the submission is focused on demonstrating that the new devices (Zinc Oxide Cem, comprising Carboxylate Cem and Phosphate Cem) are "substantially equivalent to other legally marketed devices in the United States." This means the manufacturer is asserting that their devices perform in a "similar manner to and is intended for the same use as the products marketed by Scientific Pharmaceuticals Inc." (K993324 and K982913).

In a 510(k) submission, especially for devices claiming substantial equivalence, the focus is often on comparing the new device's characteristics (materials, design, intended use, performance data if available) to those of the predicate device(s). If the predicate devices already met certain performance standards or had established safety and effectiveness, the new device aims to show it performs at least as well, or has similar characteristics, without necessarily conducting entirely new, extensive clinical trials or performance studies against novel acceptance criteria.

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