Prosthetic devices · 21 CFR 872 Subpart D

Resin Applicator

FDA device type “Applicator, Resin”.

FDA codeKXRClass121 CFR872.3140Pathway510(k) exempt
Companies listing it
9959 makers
Brands and models
163
510(k) clearances
30 in five years
FDA name
Applicator, Resin
1977: 11978: 11983: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list KXR

99 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
DiaDent Group InternationalSouth KoreaMakerBrush Handle · Brush Tips · Mixing pad · Mixing Well242026
Shofu IncJapanMakerPORCELAIN BRUSH ART · PORCELAIN BRUSH ART SET · PORCELAIN BRUSH SET ART · UNI BRUSH962025
Sybron Dental SpecialtiesUnited StatesMakerBrushes · Disposable Applicators2032026
Ultradent Products, Inc.United StatesMakerBlack Mini Brush Tips · Inspiral Brush Tips · Opal Red Tips · Opal Seal Tips952026
Ivoclar Vivadent, AGUnited StatesMakerOptraSculpt · OptraSculpt Pad942026
Kuraray Noritake Dental, Inc.JapanMakerApplicator brush (endo<black>) · Applicator brush (fine<silver>) · Applicator brush (superfine<white>) · Disposable brush tips (black) · +1322025
Inter-Med, Inc.United StatesMakerBendable tip · Blue Flo · Composite Brush · Composite Brush Handle · +1272026
Premier Dental Products CompanyUnited StatesMakerBioGreen Biodegradable Micro-Applicators282026
Young Innovations IncUnited StatesMakerESPE/Bisco/Flowthru/Ultradent/Tokuyama · Micro Applicators · Microbrush · Microbrush X · +3232025
Sdi LimitedAustraliaMakerComplet Applicator · Points · Riva Applicator · Riva Applicator 2 · +182022
Centrix, Inc.United StatesMakerBenda Brush, Benda Micro442025
Vericom Co., Ltd.South KoreaMakerEAZI-APPLICATOR202026
Imicryl Dis Malzemeleri Sanayi VE Ticaret ASTürkiyeMakerDispensing Gun, Glass Ionomer Capsule Gun, Compomer Capsule Gun52022
Premium Plus (Dongguan) LimitedChinaMakerBrush applicator, brush tips, applicators · Micro Applicators22025
HDI Inc.South KoreaMakerDenu Stick Free22022
DMG Chemisch-Pharmazeutische Fabrik GmbHGermanyMakerConstic Accessories · Ecu-Pen Microtip Applicator · Endobrushes 25 St USA · Endobrushes Black 25 St USA · +342022
Sewon Medix, Inc.South KoreaMakerPlastic Coping (CPC450B, CPC450S)22023
Pulpdent CorporationUnited StatesMakerACTIVA-SPENSER · Core Forms · Pulpdent Brush Handle · Pulpdent Brush tips · +11072021
Tokuyama Dental CorporationJapanMakerBrush No. 24192021
CAO Group, Inc.United StatesMakerFE Scrub Tip · Liqua Tip · Visco Tip132020
Crown Delta Corp.United StatesMakerZerofloX112013
Prime Dental Manufacturing, Inc.United StatesMaker—92012
ITENA ClinicalFranceMakerAPPLICATOR, RESIN82017
Addent, Inc.United StatesMakerCoMax72019
B&L Biotech Co., Ltd.South KoreaMakerCOMO · NGR#1 · NGR#2 · POMO12006
Debo Medical Technology (Shijiazhuang) Co., Ltd.ChinaMakerMicro Applicator Brush, Mikxing Wells, micro applicator brush——
Huanghua Promisee Dental Co., LtdChinaMakermicro applicator · Perfect Gingival Brushes——
Falcon Surgical Co. (Pvt.) Ltd.PakistanMakerAPPLICATOR, RESIN——
Medcave Private LimitedPakistanMakerApplicator Resin——
Shanghai Dochem Industries Co., Ltd.ChinaMakerBendable brush applicator · composite brush and replaceable tip · Micro Applicator · Valustick Sticky Applicator——
Shanghai Jolly Industrial Co., Ltd.ChinaMakerApplicator resin, prebent tips · Dental composite brush——
Shanghai Lions Industrial Co., Ltd.ChinaMakerApplicator Resin, prebent tips · dental Composite brush——
Tangshan Zhengtong Exhibition Co., Ltd.ChinaMakerMicro Applicators, Brush Applicators——
Solventum US LLCUnited StatesMaker———
Anqing Clean Dental Instrument Technology Co LtdChinaMakerCoMax/ APPLICATOR, RESIN · Flow tips/ prebent tips (APPLICATOR, RESIN)——
Hubei Guarddent Medical Technology Co.,LtdChinaMakerMicro Applicator Brush, Mixing Wells——
Jiangsu Yabaobao Medical Instrument Co.,Ltd.ChinaMakerMICRO BRUSH APPLICATOR——
TF New Material Sci and Tec Co.,ltdChinaMakermicro-brushes brush applicators——
Hefei Xingcheng Sanitary Products CO.,LTDChinaMakerDental micro Applicator · Impression Material Gun · Mixing pad · Mixing tip · +1——
Mount Blonck TradingPakistanMakerAPPLICATOR, RESIN——
HuangHua DK Dental Co., LTD,ChinaMakerPrebent Tips——
Boen Healthcare Co LtdChinaMakerResin Applicator——
Erskine DentalAustraliaMakerPreeben——
Xiantao S&J Protective Products Co., LtdChinaMakerMicro Applicators——
Hefei Mlush Sanitary Products Co., LtdChinaMakermicro-brushes brush applicators——
Elite Dental LabChinaMakerResin Applicator——
Jordco IncUnited StatesMakerPure Bond Dispenser: Accessory to Resin Applicator——
Wellmed Dental Medical Supply Co., Ltd.ChinaMakerApplicator Resin——
Cordica Medical (Formally Team Technologies, Inc)United StatesMakerResin Applicator——
Guangxi Ehall Medical Technology Co.,LtdChinaMakerMicro Applicator, Adhesive Tip——
Win Wings Corp.PakistanMakerAPPLICATOR, RESIN——
Greatcare 4u sdn bhdMalaysiaMakerDisposable micro applicators——
Fomed Industries Inc.ChinaMakerMixing Bowl——
medmix Switzerland AGSwitzerlandMakerMicro Applicator, ZerofloX——
Denbur IncUnited StatesMakerMulti-Brush Original Blue, Multi-Brush Multi-Colors, Magic-Brush, Nano-Brush, Maxi-Brush, Master-Brush, VO-Brush——
Smile Line SASwitzerlandMakerCompo Brush——
Jiangsu JianYu Health Medical Co., LtdChinaMakerResin Applicator——
Gebruder Renggli AGSwitzerlandMakerOptraSculpt——
credentis agSwitzerlandMakerPVA pad——
Dentsply Sirona, Inc.United StatesContract manufacturer—1482026
Zest Anchors, LLCUnited StatesManufacturer—262026
Bisco, Inc.United StatesContract manufacturerBISCO APPLICATORS · BISCO BRISTLE APPLICATOR · BRUSH TIPS · DISPOSABLE MIXING WELLS · +4882025
Cosmedent, Inc.United StatesRepacker / relabelerCosmedent Brushes272024
Dentscare LtdaBrazilManufacturerAllcem Core Mixing tips102024
Den-Mat Holdings, LLCUnited StatesManufacturerMulti-Brush® Disposable Dental Applicator82026
Pac-Dent Inc.United StatesContract manufacturer—52022
Keystone IndustriesUnited StatesContract manufacturerPrehma Micro Applicators22025
Ortho Organizers, Inc.United StatesManufacturerMini-Molds82025
Tp Orthodontics, Inc.United StatesManufacturerDisposable brushes · Disposable Spatulas · Foam Pellets52022
DSI Dental Solutions LtdIsraelManufacturerDSI Veneer Stick Adhesive Tip Holders22025
Reliance Orthodontic Products, Inc.United StatesContract manufacturerA2 Aligner Attachment322021
George Taub Products & Fusion Co., Inc.United StatesManufacturer—21986
Rmo, Inc.United StatesManufacturerTruLock BRUSH and Sticks11990
DMG America, L.L.C.United StatesContract manufacturerApplicator, Resin - DR. I.B. BIDERMAN'S BEND IT ANY W12013
Jersey Dental SuppliesUnited StatesRepacker / relabelerBlack Mini Brush Tips; Inspiral Brush Tips; Opal Red Tips; Opal Seal Tips——
Dentimed Sao Joao LLCUnited StatesRepacker / relabelerTOSCANA——
TitanLinks Logistics LLCUnited StatesRepacker / relabelerBrush Applicator——
Jmu Dental, Inc.United StatesRepacker / relabelerMICRO APPLICATOR; VALUSTICK STICKY APPLICATOR; BENDABLE BRUSH APPLICATOR; COMPOSITE BRUSH AND REPLACEABLE TIP——
Patterson Companies, Inc.United StatesForeign exporterPatterson Disposable Brush Applicators——
Soher Med LimitedHong Kong SAR ChinaForeign exporterApplicatory Resin——
Premium Plus DentalUnited StatesListerPremium Plus Brush Applicators · Premium Plus Micro Applicator——
Ortho Arch Company IncUnited StatesRepacker / relabelerMini-Molds——
Csy International LLCUnited StatesRepacker / relabelerJ&J ORTHODONTICS——
Yizur LtdHong Kong SAR ChinaForeign exporterApplicator——
CARGUS International Inc.United StatesRepacker / relabelerCargus Brush Tips · MARK3 Infusor Tips——
LLD Care d.o.o.CroatiaForeign exporterBiogreen applicators——
Maxill Inc.United StatesForeign exporterMaxill——
Ortho Solutions LCUnited StatesContract manufacturerDynaFlex Bonding Brushes——
Shanghai smedent medical instrument co., ltd.ChinaForeign exporterapplicator, resin - dental applicators, mixing pad; mixing well; brush handle, brush tips;——
ATOMO Dental, Inc.United StatesRepacker / relabelerMicro Applicator; Valustick Sticky Applicator; Bendable brush applicator; composite brush and replaceable tip——
HI Medical Co., Ltd.South KoreaForeign exporterYoung Innovations——
Sanicure BVNetherlandsForeign exporter———
indigodental GmbHGermanyForeign exporter———
Kash Sales Inc.CanadaForeign exporter———
3D Dental Designs and Development LLCUnited StatesContract manufacturer———
Bright Supply IncUnited StatesLister———
MN Health Inc,United StatesRepacker / relabeler———
Mainline Medical Dental SupplyCanadaForeign exporter———
Oketz Logistics LLCUnited StatesRepacker / relabeler———

510(k) clearances

Decided510(k)DeviceApplicant
4 Oct 1983K832662DENTAL SYRINGE SYSTEM-VARIOUS STYLESCentrix, Inc.
29 Sep 1978K781098BRUSH, APPLICATOR3M Company
31 Jan 1977K770160CERAMIST BRUSHDeringer-Ney, Inc.

Official records: FDA product classification for KXR · 21 CFR 872.3140.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026