FDA.report

510(k) K234043

Device
3M? Transbond? Orthodontic Adhesive
Applicant
3M Unitek Orthodontic Products
510(k) number
K234043
Product code
DYH
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-22
Date received
2023-12-21
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
Chandrapaul Parsram
Address
2724 S. Peck Rd. Monrovia CA US 91016 91016

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K210115FiteBac CC OrthoSealLargent Health, LLC2021-07-29
K202276BracePaste Band and Build LCAmerican Orthodontics2020-08-14
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K183147BrackFixVoco GmbH2019-03-01
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K160782BracePaste AdhesiveAmerican Orthodontics2016-10-14
K161684Quantum LBReliance Orthodontic Products, Inc.2016-10-06
K150128GC Ortho Connect, GC Ortho Etching GelGc Orthodontics America, Inc.2015-07-16
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