ULTRACEM— 510(k) K132255

Name: FDA 510(k) clearance K132255
Creator: U.S. Food and Drug Administration
Published: 2013-10-24

Substantially Equivalent

Ultradent Products Inc. / Oratech, LLC

FDA 510(k) clearance K132255 for ULTRACEM, Substantially Equivalent on 2013-10-24. Applicant: Ultradent Products Inc. / Oratech, LLC. Device class: 2.

Clearance details

Applicant: Ultradent Products Inc. / Oratech, LLC
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2013-07-19
Decision date: 2013-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

Download summary PDF View on FDA.gov ↗

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