ORTHODONTIC CERAMIC BRACKETS— 510(k) K042178

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K042178 for ORTHODONTIC CERAMIC BRACKETS, Substantially Equivalent on 2004-08-30. Applicant: Dentsply Intl.. Device class: 2.

Clearance details

Applicant: Dentsply Intl.
Product code: Code NJM
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2004-08-11
Decision date: 2004-08-30
Decision: Substantially Equivalent
Clearance type: Special
Location: York, PA, 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.