RC-Prime Root Canal Preparation Cream— 510(k) K200330

Name: FDA 510(k) clearance K200330
Creator: U.S. Food and Drug Administration
Published: 2020-07-06

Substantially Equivalent

Pac-Dent, Inc.

FDA 510(k) clearance K200330 for RC-Prime Root Canal Preparation Cream, Substantially Equivalent on 2020-07-06. Applicant: Pac-Dent, Inc.. Device class: Unclassified.

Clearance details

Applicant: Pac-Dent, Inc.
Product code: Code KJJ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2020-02-10
Decision date: 2020-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, 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.