MTA ROOT CANAL SEALER— 510(k) K080203

Substantially Equivalent

Dentsply Interntional

FDA 510(k) clearance K080203 for MTA ROOT CANAL SEALER, Substantially Equivalent on 2008-03-26. Applicant: Dentsply Interntional. Device class: 2.

Clearance details

Applicant: Dentsply Interntional
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2008-01-28
Decision date: 2008-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, 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.