FDA.reportPublic FDA data

Dental matrix band kit

Definition
A collection of non-sterile devices intended for the temporary introduction of a dental matrix band to form a mould around a tooth prior to tooth restoration using a direct restorative material (not included). Often referred to as a dental matrix system, it includes a matrix band(s), matrix band tensioner, dental wedge, and appropriate forceps. This device is reusable after appropriate cleaning/sterilization of the reusable instruments, and when the consumable products have been replenished.
GUDID devices
256
Last updated
2026-09-04 23:10:56

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810226102231AiraAIRA, LLC1041012026-08-26
00810226102248AiraAIRA, LLC1041022026-08-26
00883205044617Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.99312026-06-26
00883205044624Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.99322026-06-26
00883205044631Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.99332026-06-26
00883205044648Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.99352026-06-26
00883205044655Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.99362026-06-26
00810038090221Composi-Tight 3D FusionGARRISON DENTAL SOLUTIONS, L.L.C.FX-HHF-502022-01-05
00887919890966Brasseler USAPeter Brasseler Holdings, LLC209021-B2023-01-31
00887919890997Brasseler USAPeter Brasseler Holdings, LLC209022-B2023-01-31
00887919891321Brasseler USAPeter Brasseler Holdings, LLC209013-B2023-01-31
00887919891352Brasseler USAPeter Brasseler Holdings, LLC209009-B2023-01-31
14026704799371PILLINGTELEFLEX INCORPORATEDIPN0201002022-12-08
D832MTX2KIT1PlasdentPLASDENT CORPORATIONMTX2-KIT2022-01-27
D832MTXKIT1PlasdentPLASDENT CORPORATIONMTX-KIT2022-01-27
D9498271512Starter Bioclear Evolve KitBioclear Matrix Systemsw/ Orange2024-01-09
54026704799379PILLINGTELEFLEX INCORPORATEDIPN0201002022-12-08
E29968900myQuickmat Prime KitPolydentia SA68902025-06-16
E29969010Unica Master KitPolydentia SA69012025-06-16
00359883004347Dual-Force™ Sectional Matrix System Ring ForcepsDEN-MAT HOLDINGS, LLC2090092025-03-12
00359883004354Dual-Force™ Sectional Matrix System Matrix Band Punch PliersDEN-MAT HOLDINGS, LLC2090132025-03-12
00359883004392Dual-Force™ Sectional Matrix System Starter Kit with Ultra-WrapDEN-MAT HOLDINGS, LLC2090212025-03-12
00359883004408Dual-Force™ Sectional Matrix System Complete Kit w/Ultra-WrapDEN-MAT HOLDINGS, LLC2090222025-03-12
00810038091129Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.QPL2025-02-16
00810038091136Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.QK4-M2025-02-16
00810038091143Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.QK42025-02-16
00810038091150Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.QBL2025-02-16
00810038091167Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.QOR2025-02-16
00810038091174Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.QGR2025-02-16
00810038091181Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.QPL-M2025-02-16
00810038091198Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.QBL-M2025-02-16
00810038091204Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.QOR-M2025-02-16
00810038091211Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.QGR-M2025-02-16
00810038091334Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.Q-KHF-402025-02-16
00810038091358Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.Q-KHF-002025-02-16
00810038091365Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.Q-KHF-112025-02-16
00810038091372Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.Q-KHF-142025-02-16
00810038091402Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.QR-KHF-112025-02-16
00810038091419Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.Q-KHF-102025-02-16
00810038091426Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.QR-KHF-142025-02-16
00810038091433Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.QR-KHF-102025-02-16
00810038091440Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.Q-KHF-00-R2025-02-16
D9498271712Evolve All-in-One Select KitBioclear Matrix SystemsFull2024-12-03
D9498271612Evolve All-in-One Select KitBioclear Matrix SystemsStudent/EM2024-10-22
D9499000412BT, Evolve, & DWBioclear Matrix SystemsSamples for 3M Heaters2024-08-20
00348783004571Premier X5 Sectional Matrix SystemPREMIER DENTAL PRODUCTS COMPANY90611502024-07-12
00348783004588Premier X5 Sectional Matrix SystemPREMIER DENTAL PRODUCTS COMPANY90611552024-07-12
00348783004700Premier X5 Sectional Matrix SystemPREMIER DENTAL PRODUCTS COMPANY90611992024-07-12
D9498270912Evolve Matrix Procedure KitBioclear Matrix SystemsBrazil2024-07-10
00883205033772Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.48312024-06-08
00883205033789Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.48322024-06-08
00883205033796Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.48332024-06-08
00883205033802Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.48342024-06-08
00883205033819Halo Sectional Matrix SystemULTRADENT PRODUCTS, INC.48352024-06-08
D9498271312Select Bioclear Evolve Posterior KitBioclear Matrix SystemsSelect2024-04-05
D9498271412Bioclear Evolve Posterior KitBioclear Matrix SystemsSelect Add-On Kit2024-04-05
EMICEMAM01Ena MatrixMICERIUM SPAEMAM2023-09-29
D9498010103Black Triangle KitBioclear Matrix SystemsProcedure Kit2023-09-11
D9498010302Original Anterior KitBioclear Matrix SystemsStarter - India2023-09-11
D9498020022Diastema Closure KitBioclear Matrix SystemsMini2023-09-11
D9498060012Biofit SS Posterior KitBioclear Matrix SystemsMini2023-09-11
D9498060022Biofit SS Posterior KitBioclear Matrix SystemsAssorted 10ct2023-09-11
D9498180012Biofit HD Posterior KitBioclear Matrix SystemsMini2023-09-11
D9498180022Biofit HD Posterior KitBioclear Matrix SystemsAssorted 10ct2023-09-11
D9498180032Biofit HD Posterior KitBioclear Matrix SystemsCustom Intro (France)2023-09-11
D9498200012HD Anterior Matrix KitBioclear Matrix SystemsMini HD A Series Kit2023-09-11
D9498200013HD Anterior Matrix KitBioclear Matrix SystemsMini HD A Series Kit2023-09-11
D9498201962HD Anterior Matrix KitBioclear Matrix SystemsStarter2023-09-11
D9498201972HD Anterior Matrix KitBioclear Matrix SystemsComplete2023-09-11
D9498270513Bioclear Evolve Posterior KitBioclear Matrix SystemsComplete2023-09-11
D9498270613Bioclear Evolve Posterior KitBioclear Matrix SystemsStarter2023-09-11
D9499000312Sales Rep/Virtual Demo KitBioclear Matrix SystemsSales Rep/Virtual Demo Kit2023-09-11
D9498010102Black Triangle KitBioclear Matrix SystemsProcedure Kit2023-09-10
D9498010252Anterior Matrix KitBioclear Matrix SystemsStarter2023-09-10
D9498010262Original Anterior KitBioclear Matrix SystemsStarter2023-09-10
D9498010272Original Anterior KitBioclear Matrix SystemsComplete2023-09-10
D9498050812Biofit BLUE Posterior KitBioclear Matrix SystemsComplete2023-09-10
D9498180512Biofit Posterior KitBioclear Matrix SystemsCombined2023-09-10
D9498180812Biofit HD Posterior KitBioclear Matrix SystemsComplete2023-09-10
D9498270512Bioclear Evolve Posterior KitBioclear Matrix SystemsComplete2023-09-10