MYSTIQUE MB CERAMIC BRACKETS— 510(k) K082974

Name: FDA 510(k) clearance K082974
Creator: U.S. Food and Drug Administration
Published: 2008-11-07

Substantially Equivalent

Dentsply Interntional

FDA 510(k) clearance K082974 for MYSTIQUE MB CERAMIC BRACKETS, Substantially Equivalent on 2008-11-07. Applicant: Dentsply Interntional. Device class: 2.

Clearance details

Applicant: Dentsply Interntional
Product code: Code NJM
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2008-10-06
Decision date: 2008-11-07
Decision: Substantially Equivalent
Clearance type: Special
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.