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K Number
K092384
Device Name
LIQUICORD
Manufacturer
CENTRIX, INC.
Date Cleared
2009-11-04

(91 days)

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

LiquiCord is intended for temporary retraction and hemostatsis of the gingival margin during dental procedures such as dental impressions and the seating of temporary and permanent restorations

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called "LiquiCord," which is a dental product.

The letter does not include:

  • A table of acceptance criteria or reported device performance.
  • Details about specific studies, such as sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance.
  • Information about how ground truth was established for training or test sets.

The letter primarily focuses on the FDA's determination of substantial equivalence to a predicate device and outlines regulatory responsibilities. It states the "Indications for Use" but does not delve into the performance metrics or study designs used to demonstrate the device's efficacy or safety.

N/A