Fill-Up!— 510(k) K150218

Substantially Equivalent

Coltene/Whaledent AG

FDA 510(k) clearance K150218 for Fill-Up!, Substantially Equivalent on 2015-06-23. Applicant: Coltene/Whaledent AG. Device class: 2.

Clearance details

Applicant: Coltene/Whaledent AG
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2015-01-30
Decision date: 2015-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Altstätten, CH

Download summary PDF View on FDA.gov ↗

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