DynaFlex Clear Brackets & Buttons— 510(k) K230225

Substantially Equivalent

Dyna Flex

FDA 510(k) clearance K230225 for DynaFlex Clear Brackets & Buttons, Substantially Equivalent on 2023-06-05. Applicant: Dyna Flex. Device class: 2.

Clearance details

Applicant: Dyna Flex
Product code: Code NJM
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2023-01-27
Decision date: 2023-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Saint Louis, MO, US

Download summary PDF View on FDA.gov ↗

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More clearances from Dyna Flex

Data sourced from openFDA. This site is unofficial and independent of the FDA.