Search Results

Linings for class I and II cavities filled with composite
Core build-ups
Fillings in deciduous teeth
Fillings in class I cavities located in non-occlusal load bearing areas
Fillings in class V cavities if the esthetics are not of primary importance
Temporary fillings in class I and II cavities

KETAC®-MOLAR QUICK is a dental glass ionomer cement (other than zinc oxideeugenol) to serve e.g. as a temporary tooth filling and is classified according to 21 C.F.R. § 872.3275(b) as a class II device.
ESPE is submitting this Special 510(k) for modifications to its glass ionomer restorative cement KETAC®-MOLAR. The modified material is characterized by a shorter setting time. The material will be marketed under the name KETAC®-MOLAR Quick.
Like KETAC®-MOLAR, KETAC®-MOLAR QUICK is available in capsules tradenamed APLICAP®.

The provided text describes a 510(k) submission for a dental glass ionomer cement called KETAC®-MOLAR QUICK. This is a medical device, and the submission is for a modification (shorter setting time) to an existing predicate device (KETAC®-MOLAR).

The information provided does not contain details regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment that would be typically associated with an AI/ML-powered device or a study proving performance against specific metrics.

The document primarily focuses on establishing substantial equivalence to a predicate device based on:

• Intended use: Both KETAC®-MOLAR QUICK and KETAC®-MOLAR have the same intended use.
• Operating principle: Both devices work on the same operating principle.
• Chemical design: Both devices incorporate the same basic chemical design.
• Shelf life: Both devices have the same shelf life.
• Manufacturing and packaging: Both devices are manufactured and packaged using the same materials and processes.
• Chemical components: All chemical components of KETAC®-MOLAR QUICK are either part of the predicate device, found in other cleared devices, or described in a pharmacopoeia. This eliminates the need for additional biocompatibility testing.
• Modification: The primary modification is a shorter setting time.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria, study details, and data provenance based on the given text, as these types of studies were not conducted or reported for this specific medical device submission. The substantial equivalence argument is based on material and functional similarity, not on performance metrics against a pre-defined set of acceptance criteria in a clinical study as would be seen for a diagnostic or AI device.

Ask a specific question about this device