OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802— 510(k) K071055

Name: FDA 510(k) clearance K071055
Creator: U.S. Food and Drug Administration
Published: 2007-05-03

Substantially Equivalent

Ultradent Products, Inc.

FDA 510(k) clearance K071055 for OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802, Substantially Equivalent on 2007-05-03. Applicant: Ultradent Products, Inc.. Device class: 2.

Clearance details

Applicant: Ultradent Products, Inc.
Product code: Code DYW
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2007-04-16
Decision date: 2007-05-03
Decision: Substantially Equivalent
Clearance type: Special
Location: South Jordan, UT, 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.