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K Number
K091494
Device Name
FLEXITIME FLOW
Manufacturer
HERAEUS KULZER, INC.
Date Cleared
2009-07-31

(72 days)

Product Code
ELW,76E
Regulation Number
872.3660
Type
Traditional
Panel
DE
Reference & Predicate Devices
K000629,K003930
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Flexitime Light Flow/Flexitime Medium Flow each is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridge, edentulous and partial impressions.

Device Description

Dental Impression Material

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a dental impression material (Flexitime Light Flow / Medium Flow). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with acceptance criteria and device performance in the manner typically associated with clinical trials or AI/software validation.

Therefore, the requested information elements (1-9) which pertain to acceptance criteria, specific study designs, sample sizes, expert ground truth, adjudication methods, and AI performance metrics are not applicable to this 510(k) submission.

The document states:

  • "No performance standards have been established for this type of device."
  • "The results of device performance testing demonstrated that it is suitable for use as an impression material, Flexitime Flow has been designed and manufactured to perform in a manner substantially equivalent to that of the predicate devices."

This indicates that the focus was on demonstrating that the new device performs similarly to existing, approved devices, rather than meeting specific quantifiable performance criteria through a rigorous study as described in your request. Comparisons would typically involve physical and chemical properties relevant to dental impressions, but the details of such tests are not provided in this excerpt.

§ 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).