FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW— 510(k) K102770

Name: FDA 510(k) clearance K102770
Creator: U.S. Food and Drug Administration
Published: 2010-12-21

Substantially Equivalent

Heraeus Kulzer, LLC

FDA 510(k) clearance K102770 for FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW, Substantially Equivalent on 2010-12-21. 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: 2010-09-24
Decision date: 2010-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, 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.