KROMATICA COLOR CHANGING ALGINATE— 510(k) K974894

Substantially Equivalent

Matech, Inc.

FDA 510(k) clearance K974894 for KROMATICA COLOR CHANGING ALGINATE, Substantially Equivalent on 1998-02-12. Applicant: Matech, Inc.. Device class: 2.

Clearance details

Applicant: Matech, Inc.
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1997-12-31
Decision date: 1998-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, US

Download summary PDF View on FDA.gov ↗

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