IMPLANT HANDPIECES— 510(k) K051661

Substantially Equivalent

Sirona Dental Systems GmbH

FDA 510(k) clearance K051661 for IMPLANT HANDPIECES, Substantially Equivalent on 2005-09-06. Applicant: Sirona Dental Systems GmbH. Device class: 1.

Clearance details

Applicant: Sirona Dental Systems GmbH
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2005-06-22
Decision date: 2005-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, 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.