FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502— 510(k) K051750

Name: FDA 510(k) clearance K051750
Creator: U.S. Food and Drug Administration
Published: 2005-09-19

Substantially Equivalent

Ultradent Products, Inc.

FDA 510(k) clearance K051750 for FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502, Substantially Equivalent on 2005-09-19. Applicant: Ultradent Products, Inc.. Device class: 2.

Clearance details

Applicant: Ultradent Products, Inc.
Product code: Code LBH
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 2005-06-29
Decision date: 2005-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

Download summary PDF View on FDA.gov ↗

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