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K Number
K152826
Device Name
NoCord
Manufacturer
CENTRIX, INC.
Date Cleared
2016-05-27

(241 days)

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

NoCord with astringent is a low viscosity vinyl polysiloxane impression material which is indicated for use as the wash material when the tray/wash technique is performed for indirect dental restorations. When applied as the wash material, NoCord

  1. Retracts the gingival tissue to expose the sub-gingival margin
  2. Controls gingival bleeding
  3. Reproduces the structure of a patient's teeth and gums
Device Description

NoCord is a low viscosity vinyl polysiloxane impression material.

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for a dental impression material without any information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the information requested in your prompt.

§ 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).