LC GLOSSFILL XR— 510(k) K182778

Name: FDA 510(k) clearance K182778
Creator: U.S. Food and Drug Administration
Published: 2019-04-22

Substantially Equivalent

S&C Polymer Silicon- Und Composite Spezialitaeten GmbH

FDA 510(k) clearance K182778 for LC GLOSSFILL XR, Substantially Equivalent on 2019-04-22. Applicant: S&C Polymer Silicon- Und Composite Spezialitaeten GmbH. Device class: 2.

Clearance details

Applicant: S&C Polymer Silicon- Und Composite Spezialitaeten GmbH
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2018-10-01
Decision date: 2019-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elmshorn, DE

Download summary PDF View on FDA.gov ↗

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