FDA.reportPublic FDA data

510(k) K231817

Device
AlignerFlow LC
Applicant
Voco GmbH
510(k) number
K231817
Product code
DYH
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-01
Date received
2023-06-21
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
Verena Kollek
Address
Anton-Flettner-Str. 1-3 Cuxhaven DE 27472 27472

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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K242537BracePaste Fluoride SealantAmerican Orthodontics Corp.2024-08-27
K2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic Products2023-12-22
K214054TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520Tp Orthodontics, Inc.2022-10-14
K210115FiteBac CC OrthoSealLargent Health, LLC2021-07-29
K202276BracePaste Band and Build LCAmerican Orthodontics2020-08-14
K192682Orthocem, Ortho BiteDentscare Ltda2020-08-14
K193388GlassLok Kits, GlassLok Powder, GlassLok LiquidReliance Orthodontic Products, Inc.2020-04-27
K183147BrackFixVoco GmbH2019-03-01
K173020OBA-MCP, Orthodontic Bracket Adhesive with MCPPulpdent Corporation2018-01-17
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
K143667GC KommonBaseGc Orthodontics America, Inc.2015-05-07
K142886DMRC Self-Cure Bracket Adhesive One Step and PrimerDanville Materials, LLC2015-03-18