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Position® Penta and Position® Penta Quick are indicated for use for impressions for temporary restorations, preliminary impressions, opposing dentitians and orthodontic models.

Position® Penta and Position® Penta Quick are slightly modified impression materials. Position® Penta, Position® Penta Quick and Dimension® Penta H are all composed of a base paste and catalyst. Position® Penta, Position® Penta Quick and Dimension® Penta H have the same catalyst composition except for use of a pigment identified as an alternative in the Dimension® Penta 510(k). The base paste composition of the products are similar, with the exception of: (1) variations of ingredient amounts; (2) use in Position® Penta and Position® Penta Quick of a new form/chemical structure of a previously used ingredient (silyl polyethylene oxides); and (3) use of new pigments identified as alternatives in the Dimension® Penta 510(k).

The provided text is a 510(k) summary for a medical device (Position® Penta and Position® Penta Quick impression materials) and does not contain information about acceptance criteria or a study proving that the device meets those criteria.

Instead, the document focuses on:

• Substantial Equivalence: Comparing the new devices (Position® Penta and Position® Penta Quick) to a predicate device (Dimension® Penta H).
• Device Description: Discussing modifications made to the impression materials.
• Intended Use: Listing the applications for the impression materials.
• Biocompatibility Tests: Mentioning that these were undertaken, but not detailing results or acceptance criteria.
• Regulatory Communication: Providing the FDA's letter of clearance.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them based on the provided text. The output will reflect the absence of this information.

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