KORLEX-GR GINGIVAL RETRACTION PASTE— 510(k) K053329

Name: FDA 510(k) clearance K053329
Creator: U.S. Food and Drug Administration
Published: 2006-02-15

Substantially Equivalent

Biotech One, Inc.

FDA 510(k) clearance K053329 for KORLEX-GR GINGIVAL RETRACTION PASTE, Substantially Equivalent on 2006-02-15. Applicant: Biotech One, Inc.. Device class: Unclassified.

Clearance details

Applicant: Biotech One, Inc.
Product code: Code MVL
Device class: Unclassified
Advisory panel: Unknown
Date received: 2005-12-01
Decision date: 2006-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, CA, US

Download summary PDF View on FDA.gov ↗

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