GingiDent Gingival Retraction Paste— 510(k) K162662

Name: FDA 510(k) clearance K162662
Creator: U.S. Food and Drug Administration
Published: 2017-10-20

Substantially Equivalent

Pac-Dent International, Inc.

FDA 510(k) clearance K162662 for GingiDent Gingival Retraction Paste, Substantially Equivalent on 2017-10-20. Applicant: Pac-Dent International, Inc.. Device class: Unclassified.

Clearance details

Applicant: Pac-Dent International, Inc.
Product code: Code MVL
Device class: Unclassified
Advisory panel: Unknown
Date received: 2016-09-26
Decision date: 2017-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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