PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM— 510(k) K061252

Name: FDA 510(k) clearance K061252
Creator: U.S. Food and Drug Administration
Published: 2007-02-12

Substantially Equivalent

Primus Consulting

FDA 510(k) clearance K061252 for PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM, Substantially Equivalent on 2007-02-12. Applicant: Primus Consulting. Device class: 2.

Clearance details

Applicant: Primus Consulting
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 2006-05-04
Decision date: 2007-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bradenton, FL, 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.