PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER— 510(k) K033675

Name: FDA 510(k) clearance K033675
Creator: U.S. Food and Drug Administration
Published: 2004-01-15

Substantially Equivalent

Sirona Dental Systems GmbH

FDA 510(k) clearance K033675 for PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER, Substantially Equivalent on 2004-01-15. Applicant: Sirona Dental Systems GmbH. Device class: 2.

Clearance details

Applicant: Sirona Dental Systems GmbH
Product code: Code KOJ
Device class: Class 2
Regulation: 21 CFR 872.6080
Advisory panel: Dental
Date received: 2003-11-24
Decision date: 2004-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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