FDA.report

510(k) K230225

Device
DynaFlex Clear Brackets & Buttons
Applicant
Dyna Flex
510(k) number
K230225
Product code
NJM
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-05
Date received
2023-01-27
Regulation
872.5470
Classification name
Bracket, Ceramic, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Matthew Malabey
Address
8050 Hawk Ridge Trl. Lake Saint Louis MO US 63367 63367

FDA Registration Numbers

Source Documents

510(k) summary PDF

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