ENDOMAX CORDLESS ENDODONTIC HANDPIECE— 510(k) K092833

Name: FDA 510(k) clearance K092833
Creator: U.S. Food and Drug Administration
Published: 2010-01-07

Substantially Equivalent

Dentamerica

FDA 510(k) clearance K092833 for ENDOMAX CORDLESS ENDODONTIC HANDPIECE, Substantially Equivalent on 2010-01-07. Applicant: Dentamerica. Device class: 1.

Clearance details

Applicant: Dentamerica
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2009-09-15
Decision date: 2010-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: City Of Industry, CA, 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.