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K Number
K053014
Device Name
POLY SILOXANE IMPRESSION MATERIAL
Manufacturer
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Date Cleared
2005-11-15

(20 days)

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

Device intended to be placed intraorally or on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Device Description

Multiple (POLY SILOXANE IMPRESSION MATERIAL)

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for a dental impression material and does not contain the information requested about acceptance criteria and study details for a device. The document is a regulatory approval, not a scientific study report.

Therefore, I cannot extract:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes for test sets or data provenance.
  3. Number of experts or their qualifications for ground truth.
  4. Adjudication method.
  5. Information on MRMC comparative effectiveness studies.
  6. Information on standalone performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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).