FDA.report

510(k) K242537

Device
BracePaste Fluoride Sealant
Applicant
American Orthodontics Corp.
510(k) number
K242537
Product code
DYH
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-27
Date received
2024-08-26
Regulation
872.3750
Classification name
Adhesive, Bracket And Tooth Conditioner, Resin
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Related Records

Applicant Contact

Contact
Luke Hetue
Address
3524 Washington Ave. Sheboygan WI US 53081 53081

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K161684Quantum LBReliance Orthodontic Products, Inc.2016-10-06
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