PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION— 510(k) K081291

Name: FDA 510(k) clearance K081291
Creator: U.S. Food and Drug Administration
Published: 2008-05-22

Substantially Equivalent

Dentsply Interntional

FDA 510(k) clearance K081291 for PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION, Substantially Equivalent on 2008-05-22. Applicant: Dentsply Interntional. Device class: 2.

Clearance details

Applicant: Dentsply Interntional
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 2008-05-07
Decision date: 2008-05-22
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.