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K Number
K974231
Device Name
POSITION PENTA, POSITION PENTA QUICK
Manufacturer
ESPE GMBH & CO. KG.
Date Cleared
1998-01-29

(78 days)

Product Code
ELW
Regulation Number
872.3660
Type
Traditional
Panel
DE
Reference & Predicate Devices
K960547
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

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).

AI/ML Overview

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.

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).