Aquasil Ultra + Smart Wetting Impression Material— 510(k) K152861

Name: FDA 510(k) clearance K152861
Creator: U.S. Food and Drug Administration
Published: 2016-03-04

Substantially Equivalent

Dentply International, Inc.

FDA 510(k) clearance K152861 for Aquasil Ultra + Smart Wetting Impression Material, Substantially Equivalent on 2016-03-04. Applicant: Dentply International, Inc.. Device class: 2.

Clearance details

Applicant: Dentply International, Inc.
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2015-09-30
Decision date: 2016-03-04
Decision: Substantially Equivalent
Clearance type: Special
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

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