Search Results

Tulip Colorswitch is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.

Tulip Colorswitch is a dental impression material based on alginate. Tulip Colorswitch has the special characteristic of being a color-changing alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to white indicating the end of the setting time in the mouth.

The provided text describes a 510(k) premarket notification for a dental impression material, "Tulip Colorswitch Alginate Impression Materials" (K032116), and the FDA's determination of substantial equivalence to a predicate device. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The FDA letter and the "Indications for Use" statement focus on regulatory approval based on substantial equivalence, general controls, and the intended use of the device. There is no mention of specific numerical performance metrics, clinical study design, sample sizes, ground truth establishment, or expert evaluations.

Therefore, I cannot provide the requested information. The document itself is a regulatory approval letter, not a performance study report.

Ask a specific question about this device