COLLADENTAL BARRIER— 510(k) K100695

Substantially Equivalent

Collamatrix, Inc.

FDA 510(k) clearance K100695 for COLLADENTAL BARRIER, Substantially Equivalent on 2013-01-03. Applicant: Collamatrix, Inc.. Device class: 2.

Clearance details

Applicant: Collamatrix, Inc.
Product code: Code NPL
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2010-03-11
Decision date: 2013-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.