ZEN CORDLESS PROPHY SYSTEM— 510(k) K101612

Substantially Equivalent

Discus Dental, LLC

FDA 510(k) clearance K101612 for ZEN CORDLESS PROPHY SYSTEM, Substantially Equivalent on 2010-06-30. Applicant: Discus Dental, LLC. Device class: 1.

Clearance details

Applicant: Discus Dental, LLC
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2010-06-09
Decision date: 2010-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, 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.