OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM)— 510(k) K053374

Name: FDA 510(k) clearance K053374
Creator: U.S. Food and Drug Administration
Published: 2006-02-21

Substantially Equivalent

Ossacur AG

FDA 510(k) clearance K053374 for OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM), Substantially Equivalent on 2006-02-21. Applicant: Ossacur AG. Device class: 2.

Clearance details

Applicant: Ossacur AG
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2005-12-05
Decision date: 2006-02-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

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