XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML— 510(k) K130647

Name: FDA 510(k) clearance K130647
Creator: U.S. Food and Drug Administration
Published: 2013-05-17

Substantially Equivalent

Heraeus Kulzer, LLC

FDA 510(k) clearance K130647 for XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML, Substantially Equivalent on 2013-05-17. Applicant: Heraeus Kulzer, LLC. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, LLC
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2013-03-11
Decision date: 2013-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

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