DENTRON SENSOR— 510(k) K080738

Substantially Equivalent

Dentron Systems, LLC

FDA 510(k) clearance K080738 for DENTRON SENSOR, Substantially Equivalent on 2008-05-13. Applicant: Dentron Systems, LLC. Device class: 2.

Clearance details

Applicant: Dentron Systems, LLC
Product code: Code EAP
Device class: Class 2
Regulation: 21 CFR 872.1810
Advisory panel: Dental
Date received: 2008-03-17
Decision date: 2008-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ormond Beach, FL, 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.