SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT— 510(k) K133527

Name: FDA 510(k) clearance K133527
Creator: U.S. Food and Drug Administration
Published: 2014-03-07

Substantially Equivalent

Osstem Germany GmbH

FDA 510(k) clearance K133527 for SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT, Substantially Equivalent on 2014-03-07. Applicant: Osstem Germany GmbH. Device class: 2.

Clearance details

Applicant: Osstem Germany GmbH
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2013-11-15
Decision date: 2014-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fariless Hills, PA, 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.