Surgical devices · 21 CFR 872 Subpart E

Matrix Retainer

FDA device type “Retainer, Matrix”.

FDA codeJEPClass121 CFR872.4565Pathway510(k) exemptCategoryDental hand instruments
Companies listing it
10776 makers
Brands and models
217
510(k) clearances
30 in five years
FDA name
Retainer, Matrix
1983: 11993: 12009: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list JEP

107 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Sybron Dental SpecialtiesUnited StatesMakerCure-Thru Matrices · Polishers · Pre-contoured Metal Bands · SuperCap Matrices, Steel, Cervical · +12032026
Ultradent Products, Inc.United StatesMakerHalo Sectional Matrix Bands · Halo Sectional Matrix Ring · Halo Sectional Matrix Wedges · Halo Sectional Non-Stick Matrix Bands · +5952026
Premier Dental Products CompanyUnited StatesMakerCure-Thru · Premier X5 Essential Kit- No Instruments · Premier X5 Forceps · Premier X5 Intro Kit · +12282026
Young Innovations IncUnited StatesMakerRETAINER, MATRIX- Astek · 19000 Pro-Matrix Narrow Band · 19001 Pro-Matrix Curve Narrow Band · 19005 Pro-Matrix Wide Band · +1232025
Pac-Dent Inc.United StatesMakeriMatrix Clear52022
Garrison Dental Solutions LLCUnited StatesMakerClearView · Composi-Tight™ 3D Matrix System · Composi-Tight™ 3DXR Matrix System · Composi-Tight® · +932024
Pacific Care LimitedHong Kong SAR ChinaMakerAstek Innovations Ltd. / Medicom12025
Pulpdent CorporationUnited StatesMakerFintrec Dead Soft Matrix Strip · Fintrec Transparent Matrix Strip · 'T'-Bands1072021
Directa ABSwedenMakerDirecta Strips · FenderMate · FenderMatePrime · ProxyPal12015
ErgoDenta ApSDenmarkMakerIvory, 5mm · Nystrom, Left · Nystrom, Left, Coated · Nystrom, Right · +4——
Zain's Medical ImagePakistanMakerMatrix Retainer · Matrix Retainer Adult · Matrix Retainer child · Retainer Child Contra Angle · +4——
Signor Seven InternationalPakistanMakerMatrix Retainer SKU 13-1354 · Matrix Retainer SKU 13-1354-E——
Shanghai Kangqiao Dental Instruments FactoryChinaMakerIvory Matrix holder · Matrix bands (bean shape ) 1#/2#/3# · matrix bands L/M/S · Tofflemire matrix · +1——
B. Ali ImpexPakistanMakerBALI · DOCTOR NICE——
Dental StudioSouth KoreaMakerMATRIX RETAINER——
Bashir Jamil & Bros. (Pvt.), Ltd.PakistanMakerBENCO TOFFLEMIRE JONIER · BENCO TOFFLEMIRE SENIOR · BENCO TOFFLEMIRE UNIVERSAL · MATRIX RETAINER TOFFLEMIRE JONIER · +2——
Practicon, Inc.United StatesMakerParaband——
3R Industria e Comercio LtdaBrazilMakerSteel Matrix Band——
Aspen Surgical ProductsUnited StatesMakerSymmetry Surgical——
Falcon Surgical Co. (Pvt.) Ltd.PakistanMakerRetainer, Matrix——
Pomee CorporationPakistanMakerChip Blower Bulb · Furnace Tongs · Laster Pumice · Matrix Retainer · +1——
Commic SurgicoPakistanMakerMatrix retainer adult, Tofflemire , ADU · Matrix retainer Nystrom——
Panorama InternationalPakistanMakerRETAINER, MATRIX, Matrix Retainers——
Denovo Dental IncUnited StatesMakerD071514 · D071515 · D071516 · D071517 · +4——
Shanghai Jolly Industrial Co., Ltd.ChinaMakerMatrix bands——
GoldenDentUnited StatesMakerAnatomical Matrix · WagoTrix Matrix Into Kit · WagoTrix Sectional Matrix System; Class W; Class X · WagoTrix Universal Matrix Ring——
Aesculap AGGermanyMakerAesculap——
Dentatus ABSwedenMakerMEC——
Shanghai Lions Industrial Co., Ltd.ChinaMakerMatrix bands——
Adolf Schweick Hardt GmbH & CoGermanyMakerMATRIX RETAINER——
Medisporex Private LimitedPakistanMakerMEDIS——
Acme EnterprisesPakistanMakerTBS Dental——
SurgicraftsPakistanMakerJEP / RETAINER, MATRIX——
Acheron Instruments (Pvt.) Ltd.PakistanMakerMatrix Retainers——
Hubei Guarddent Medical Technology Co.,LtdChinaMakerMatrix Bands——
Harf IndustriesPakistanMakerMatrix Retainer——
Silver Plus Corp.PakistanMakerRETAINER, MATRIX——
Shanghai Medical Instruments (Group) Ltd. Corp.ChinaMakermatrix retainer——
Cangzhou Lankang Medical Instruments Developing Co., Ltd.ChinaMakerKit of metal sectional contoured matrices/ matrix band——
AMD Medicom IncCanadaMakerMedicom SafeMatrix Band——
Towne Brothers (Pvt) LtdPakistanMakerJEP - RETAINER, MATRIX——
Bioclear Matrix Systems, LLCUnited StatesMakerBioclear Matrix · Biofit Matrix · BT Matrix · Evolve Matrix · +2——
Lohar Medical CompanyPakistanMakerJEP / RETAINER, MATRIX——
Mident LtdUnited KingdomMakerMatrix Retainer——
Acme Commercial Ways Ltd.PakistanMakerMatrix Retainers——
Produits Dentaires SASwitzerlandMakerTofflemire Matrix retainers——
Astar Orthodontics IncChinaMakerlingual retainer, lower · lingual retainer, upper——
Daddy D ProPakistanMakerMatrix Retainers - Tofflemire——
Nopa Instruments Medizintechnik GmbHGermanyMakerMATRIX · RETAINER——
Onvet Medical Canada Inc.CanadaMakerSureTact G3 Matrix; SureTact Classic Matrix; SureTact G6 Matrix;SureTact G8 Matrix;SureTact G9 Matrix;SureTact G7 Matrix——
SurjexPakistanMakerRETAINER, MATRIX——
Pilotis Tech LLCUnited StatesMakerIntrace USA——
Zirc Dental Products IncUnited StatesMakerMatrix Dispenser——
Dentech Corp.JapanMakerRETAINER, MATRIX——
Central Surgical Co. Pvt. Ltd.PakistanMakerMatrix Retainers——
Alvi ExpoPakistanMakerRETAINER, MATRIX——
Richbolt EnterprisesPakistanMakerRICHBOLT ENTERPRISES——
Laparomed Private LimitedIndiaMakerMATRIX BAND AND RESTRAINERS——
Atria Co.South KoreaMakerAtria——
Power Dental USAUnited StatesMaker———
E Hahnenkratt GmbHGermanyMakerHAHNENKRATT-MATRIX-RETAINER——
Shenzhen Topinnor Technology Co.,ltdChinaMakerDental base; Model: DB-01; DB-02——
LA MAISON DENTAIRE / Medirel SASwitzerlandMakerFintrec Dead Soft Matrix Strip · Fintrec Transparent Matrix Strip · Fintrec Wedges——
White Bite, Inc.United StatesMakerMatrix Band——
Vago International Manufacturing SA DE CVMexicoMakerOMNI-MATRIX ORIGINAL WINGED; ORIGNAL WINGLESS; SECTIONAL; WINGES; WINGLESS——
Dockum Research LabUnited StatesMakerWizard Wedges Anatomical Matrix · Wizard Wedges Matrix——
DSC Dental, LLCUnited StatesMakerTofflemire——
Inventex MedicalUnited StatesMaker———
Nova BiomedicalUnited StatesMakerNova Stat Profile pHOx Plus C——
Tessy Plastics Shanghai Co., Ltd.ChinaMakerPro-Matrix——
USTOMED INSTRUMENTE GmbH & Co. KGGermanyMaker———
Devemed GmbHGermanyMaker———
Gulmag InternationalPakistanMaker———
Helmut Zepf Medizintechnik GmbHGermanyMaker———
Medical Devices Group LimitedHong Kong SAR ChinaMaker———
Tekno-Medical Optik-Chirurgie GmbHGermanyMaker———
Cosmedent, Inc.United StatesRepacker / relabelerMatrix Bands272024
DentamericaUnited StatesRepacker / relabelerMYLTRIP42010
Dentatus USA Ltd.United StatesRepacker / relabelerParallel-A-Prep42004
Integra LifeSciences CorporationUnited StatesContract manufacturerJarit · Miltex · Padgett22014
Storz AM Mark GmbHGermanyContract manufacturerMatrix band · Matrix retainer22008
Aesculap, Inc.United StatesListerDENTAL INSTRUMENT22006
One DashcorpUnited StatesRepacker / relabelerValdent USA #1 Tofflemire Type Matrix Band, Stainless Steel, 01 Gauge, 025mm thick · Valdent USA #1 Tofflemire Type Matrix Band, Stainless Steel, 01 Gauge, 04mm thick · Valdent USA #1 Tofflemire Type Matrix Band, Stainless Steel, 02 Gauge, 05mm thick · Valdent USA #13 Tofflemire Type Matrix Band, Stainless Steel, 015 Gauge, 04mm thick · +8——
Wuxi Lyusmile Imp and Exp Co.,ltdChinaPrivate-label distributorDENTAL MATRIX BAND · DENTAL MATRIX HOLDER · DENTAL MATRIX RETAINER · Ivory Matrix Bands · +4——
Jersey Dental SuppliesUnited StatesRepacker / relabelerAutomix——
Dentimed Sao Joao LLCUnited StatesRepacker / relabelerANGELUS——
TitanLinks Logistics LLCUnited StatesRepacker / relabelerRetainer——
Jmu Dental, Inc.United StatesRepacker / relabelerJMU Sectional Matrix Bands——
Patterson Companies, Inc.United StatesForeign exporterPatterson Matrix Retainer——
Soher Med LimitedHong Kong SAR ChinaForeign exporterretainer——
International Orthodontics Services. PCUnited StatesRepacker / relabelerLingual 3 and 3 · Lingual 3-3——
Nordent MFG., Inc.United StatesContract manufacturerMatrix Retainers——
PDT Inc.United StatesContract manufacturer———
Yizur LtdHong Kong SAR ChinaForeign exporterRetainer——
TBS DentalUnited StatesRepacker / relabelerTBS INOX USA——
CARGUS International Inc.United StatesRepacker / relabelerMARK3® Tofflemire Type Matrix Bands——
LLD Care d.o.o.CroatiaForeign exporterPremier Matrix Refill——
Sklar CorporationUnited StatesRepacker / relabelerMatrix Band——
Dental Brands for LessCanadaForeign exporter3M ESPE——
Guangzhou Four E's Scientific Co., Ltd.ChinaContract manufacturerMatrix Bands · Matrix Retainers · Sectional Matrix System——
Greater CurveUnited StatesRepacker / relabelerGreater Curve Saliva Ejector Holder · Greater Curve Soft Sided Contra-angle Retainer · Greater Curve Soft Sided Universal Retainer——
Sanicure BVNetherlandsForeign exporter———
3D Dental Designs and Development LLCUnited StatesContract manufacturer———
Diversified Chemical Products, Inc.United StatesContract manufacturer———
Ho AssemblyUnited StatesRepacker / relabelerHo Bands——
Mainline Medical Dental SupplyCanadaForeign exporter———
Oketz Logistics LLCUnited StatesRepacker / relabeler———

510(k) clearances

Decided510(k)DeviceApplicant
17 Aug 2009K091533SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200Garrison Dental Solutions LLC
23 Sep 1993K930151OMNI-MATRIXInnovative Technology , Ltd.
8 Jun 1983K831136DOUBLE BOW TOOTH SEPARATORAlmore Intl., Inc.

Official records: FDA product classification for JEP · 21 CFR 872.4565.

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