BIOPURE MTAD ROOT CANAL CLEANSER— 510(k) K053167

Name: FDA 510(k) clearance K053167
Creator: U.S. Food and Drug Administration
Published: 2005-12-08

Substantially Equivalent

Dentsply Intl., Inc.

FDA 510(k) clearance K053167 for BIOPURE MTAD ROOT CANAL CLEANSER, Substantially Equivalent on 2005-12-08. Applicant: Dentsply Intl., Inc.. Device class: Unclassified.

Clearance details

Applicant: Dentsply Intl., Inc.
Product code: Code KJJ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2005-11-14
Decision date: 2005-12-08
Decision: Substantially Equivalent
Clearance type: Special
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

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