RONDOFLEX PLUS 360— 510(k) K042872

Substantially Equivalent

Kavo America Corporation

FDA 510(k) clearance K042872 for RONDOFLEX PLUS 360, Substantially Equivalent on 2004-11-23. Applicant: Kavo America Corporation. Device class: 2.

Clearance details

Applicant: Kavo America Corporation
Product code: Code KOJ
Device class: Class 2
Regulation: 21 CFR 872.6080
Advisory panel: Dental
Date received: 2004-10-18
Decision date: 2004-11-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Deer Field, IL, 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.