X-SMART EASY— 510(k) K092614

Substantially Equivalent

Dentsply Interntional

FDA 510(k) clearance K092614 for X-SMART EASY, Substantially Equivalent on 2009-12-02. Applicant: Dentsply Interntional. Device class: 1.

Clearance details

Applicant: Dentsply Interntional
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2009-08-26
Decision date: 2009-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Dentsply Interntional

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K082974 — MYSTIQUE MB CERAMIC BRACKETS2008-11-07
K081291 — PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION2008-05-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.