OSSTELL ISQ IMPLANT STABILITY METER— 510(k) K082523

Substantially Equivalent

Osstell AB

FDA 510(k) clearance K082523 for OSSTELL ISQ IMPLANT STABILITY METER, Substantially Equivalent on 2008-09-26. Applicant: Osstell AB. Device class: 1.

Clearance details

Applicant: Osstell AB
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2008-09-02
Decision date: 2008-09-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Alexandria, VA, US

Download summary PDF View on FDA.gov ↗

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