Image Fast Set, Image Regular Set— 510(k) K160097

Name: FDA 510(k) clearance K160097
Creator: U.S. Food and Drug Administration
Published: 2016-08-05

Substantially Equivalent

Sybron Dental Specialties

FDA 510(k) clearance K160097 for Image Fast Set, Image Regular Set, Substantially Equivalent on 2016-08-05. Applicant: Sybron Dental Specialties. Device class: 2.

Clearance details

Applicant: Sybron Dental Specialties
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2016-01-19
Decision date: 2016-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, 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.