Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DynaFlex Clear Brackets & Buttons

K-Number: K230225 · 2023-06-05

ApplicantDyna Flex
Decision Date2023-06-05
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DynaFlex Clear Brackets & Buttons is a medical device manufactured by Dyna Flex. It received FDA 510(k) clearance on 2023-06-05 under approval number K230225. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DynaFlex Clear Brackets & Buttons?

DynaFlex Clear Brackets & Buttons is a medical device that received FDA 510(k) clearance on 2023-06-05. It is manufactured by Dyna Flex. The 510(k) number is K230225.

When was DynaFlex Clear Brackets & Buttons approved by the FDA?

DynaFlex Clear Brackets & Buttons received FDA 510(k) clearance on 2023-06-05, under approval number K230225.

What company makes DynaFlex Clear Brackets & Buttons?

DynaFlex Clear Brackets & Buttons is manufactured by Dyna Flex.

What is the FDA product code for DynaFlex Clear Brackets & Buttons?

The FDA product code for DynaFlex Clear Brackets & Buttons is NJM.

Related Clinical Trials

NCT07511296 Orthognathic Surgery With Clear Aligners vs Conventional Brackets COMPLETED

Other Devices by Dyna Flex

K190583DynaFlex

Related Devices (Code: NJM)

K160957CDB Self Ligating Bracket 8FCdb Corporation K160615ORTHODONTIC CERAMIC BRACKETS 1.1Tomy, Inc. K152167BIJOU Orthodontic Ceramic BracketWorld Bio Tech Co., Ltd. K171844Inspire ICE aka Inspire ICE Clear BracketsOrmco Corporation K163467C-Line Orthodontic Ceramic BracketBiocetec Co., Ltd. K163117Alpha PureKoroad America

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑