STRAUMANN MEMBRAGEL— 510(k) K101956

Name: FDA 510(k) clearance K101956
Creator: U.S. Food and Drug Administration
Published: 2010-12-16

Substantially Equivalent

Straumann USA (On Behalf of Institut Straumann Ag)

FDA 510(k) clearance K101956 for STRAUMANN MEMBRAGEL, Substantially Equivalent on 2010-12-16. Applicant: Straumann USA (On Behalf of Institut Straumann Ag). Device class: 2.

Clearance details

Applicant: Straumann USA (On Behalf of Institut Straumann Ag)
Product code: Code NPK
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2010-07-12
Decision date: 2010-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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