ELATION MB METAL REINFORCED PLASTIC BRACKET— 510(k) K092030

Name: FDA 510(k) clearance K092030
Creator: U.S. Food and Drug Administration
Published: 2009-07-24

Substantially Equivalent

Dentsply Interntional

FDA 510(k) clearance K092030 for ELATION MB METAL REINFORCED PLASTIC BRACKET, Substantially Equivalent on 2009-07-24. Applicant: Dentsply Interntional. Device class: 2.

Clearance details

Applicant: Dentsply Interntional
Product code: Code DYW
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2009-07-06
Decision date: 2009-07-24
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.