Dental Device Guide
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Registered with FDA

Mainline Medical Dental Supply

Toronto, Canada. Lists 119 dental device types with FDA across 1 registered establishment.

FDA owner/operator10052656Foreign exporter
Device types listed
119
Brands and models
0
510(k) clearances
0as applicant
Markets registered in
1United States
Establishments
1Canada

Devices listed with FDA

What Mainline Medical Dental Supply currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Resin Tooth Shade MaterialEBF · Class 2Dental compositesLister—2016
Dental CementEMA · Class 2Dental cementsLister—2016
Resin Tooth Bonding AgentKLE · Class 2Bonding agentsLister—2016
Impression MaterialELW · Class 2Impression materialsLister—2016
Resin Temporary Crown and BridgeEBG · Class 2Temporary crown & bridge materialsLister—2016
Rebasing Repairing Relining Denture ResinEBI · Class 2Denture resins & teethLister—2018
Pit and Fissure Sealant and ConditionerEBC · Class 2Sealants & varnishesLister—2016
Ultrasonic ScalerELC · Class 2Ultrasonic scalersLister—2016
Cavity VarnishLBH · Class 2Sealants & varnishesLister—2016
Calcium Hydroxide Cavity LinerEJK · Class 2—Lister—2017
Porcelain PowderEIH · Class 2Dental ceramics & zirconiaLister—2017
Root Canal Filling ResinKIF · Class 2Root canal filling materialsLister—2016
Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2—Lister—2017
Resin Filling Material CoatingEBD · Class 2—Lister—2017
Amalgam AlloyEJJ · Class 2—Lister—2017
Orthodontic Extraoral HeadgearDZB · Class 2Retainers, expanders & headgearLister—2018
Ultraviolet Activator for PolymerizationEBZ · Class 2Curing lightsLister—2017
Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1Dental handpiecesLister—2018
Restorative and Impression Material SyringeEID · Class 1Dental hand instrumentsLister—2017
Orthodontic Metal BracketEJF · Class 1Orthodontic bracketsLister—2018
Oral Cavity Abrasive Polishing AgentEJR · Class 1Polishing & prophylaxisLister—2016
Root Canal PostELR · Class 1Root canal filling materialsLister—2017
Orthodontic Ceramic BracketNJM · Class 2Orthodontic bracketsLister—2018
Orthodontic Plastic BracketDYW · Class 2Orthodontic bracketsLister—2019
Dental NeedleDZM · Class 1Dental needles & syringesLister—2017
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsLister—2017
Amalgam Dental CapsuleDZS · Class 1—Lister—2017
Resin Impression Tray MaterialEBH · Class 1Impression traysLister—2017
Air and/or Water Syringe UnitECB · Class 1Dental hand instrumentsLister—2025
Dental Air-Powered HandpieceEFB · Class 1Dental handpiecesLister—2018
Rubber DamEIE · Class 1Rubber dam systemsLister—2017
Dental Instrument HandleEJB · Class 1Dental hand instrumentsLister—2022
Dental BurEJL · Class 1Dental burs & diamondsLister—2016
Gutta-PerchaEKM · Class 1Root canal filling materialsLister—2017
Ac-Powered Direct Drive HandpieceEKX · Class 1Dental handpiecesLister—2017
Paper Saliva AbsorberKHR · Class 1—Lister—2022
Caries Detection DeviceLFC · Class 2Caries detection devicesLister—2017
Endosseous Dental Implant AbutmentNHA · Class 2Implant abutmentsLister—2017
External Cleaning SolutionPME · Class 2—Lister—2017
Orthodontic Screw Expansion RetainerDYJ · Class 1Retainers, expanders & headgearLister—2018
Saliva Ejector MouthpieceDYN · Class 1—Lister—2017
Intraoral Dental DrillDZA · Class 1Surgical drills & motorsLister—2017
Orthodontic WireDZC · Class 1Orthodontic wires & bandsLister—2018
Orthodontic TubeDZD · Class 1Orthodontic wires & bandsLister—2018
Dental Diamond InstrumentDZP · Class 1Dental burs & diamondsLister—2021
Pulp TesterEAT · Class 2—Lister—2017
Mouth MirrorEAX · Class 1Dental hand instrumentsLister—2017
Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1—Lister—2016
Orthodontic Elastic BandECI · Class 1Orthodontic wires & bandsLister—2018
Orthodontic SpringECO · Class 1Orthodontic wires & bandsLister—2018
Orthodontic Band SetterECR · Class 1Dental hand instrumentsLister—2019
Rubber Dam ClampEEF · Class 1Rubber dam systemsLister—2019
Heat Source for Bleaching TeethEEG · Class 1Teeth whitening lightsLister—2017
Articulation PaperEFH · Class 1—Lister—2017
Dental Dressing ForcepsEFL · Class 1Dental hand instrumentsLister—2024
Roll CottonEFN · Class 1—Lister—2023
Oral Irrigation UnitEFS · Class 1Oral irrigatorsLister—2017
Over the Counter Denture CleanserEFT · Class 1Denture cleansers & adhesivesLister—2017
Manual ToothbrushEFW · Class 1ToothbrushesLister—2016
Intraoral Dental WaxEGD · Class 1—Lister—2018
Dental Surgical Tissue ScissorsEGN · Class 1Dental hand instrumentsLister—2024
X-Ray Film HolderEGZ · Class 1—Lister—2017
X-Ray Beam AlignerEHA · Class 1—Lister—2026
Abrasive DiskEHJ · Class 1Polishing & prophylaxisLister—2016
Abrasive PointEHL · Class 1Polishing & prophylaxisLister—2016
Polishing Agent StripEHM · Class 1Polishing & prophylaxisLister—2016
Preformed Impression TrayEHY · Class 1Impression traysLister—2017
Oral Cavity EvacuatorEHZ · Class 1Suction & evacuation unitsLister—2018
Operative Dental UnitEIA · Class 1Dental chairs & operative unitsLister—2020
Irrigating Endodontic Periodontic SyringeEIC · Class 1Dental hand instrumentsLister—2021
Dental Retractor AccessoriesEIF · Class 1Dental hand instrumentsLister—2017
All Types RetractorEIG · Class 1Dental hand instrumentsLister—2017
Dental Instrument Depth GaugeEIL · Class 1Dental hand instrumentsLister—2020
Collar and Crown ScissorsEIR · Class 1Dental hand instrumentsLister—2025
Crown RemoverEIS · Class 1Dental hand instrumentsLister—2023
Periodontic ProbeEIX · Class 1Dental hand instrumentsLister—2017
Dental Plastic Filling InstrumentEIY · Class 1Dental hand instrumentsLister—2024
Rubber Dam FrameEJE · Class 1Rubber dam systemsLister—2019
Cartridge SyringeEJI · Class 2Dental needles & syringesLister—2025
Wire ClaspEJW · Class 1—Lister—2018
Operative PliersEJY · Class 1Dental hand instrumentsLister—2025
Operative Margin Finishing KnifeEJZ · Class 1Dental hand instrumentsLister—2023
Operative ExplorerEKB · Class 1Dental hand instrumentsLister—2017
Operative Dental ExcavatorEKC · Class 1Dental hand instrumentsLister—2024
Operative Amalgam and Foil CondenserEKG · Class 1Dental hand instrumentsLister—2024
Operative Dental Amalgam CarverEKH · Class 1Dental hand instrumentsLister—2025
Operative Amalgam CarrierEKI · Class 1Dental hand instrumentsLister—2017
Operative BurnisherEKJ · Class 1Dental hand instrumentsLister—2017
Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1Dental hand instrumentsLister—2017
Endodontic Paper PointEKN · Class 1Root canal filling materialsLister—2017
Endodontic Pulp Canal ReamerEKP · Class 1Endodontic filesLister—2017
Root Canal Endodontic PreparerEKQ · Class 1Endodontic filesLister—2017
Endodontic Root Canal PluggerEKR · Class 1Dental hand instrumentsLister—2023
Endodontic Pulp Canal FileEKS · Class 1Endodontic filesLister—2017
Endodontic CuretteEKT · Class 1Dental hand instrumentsLister—2020
MercuryELY · Class 2—Lister—2017
Preformed CrownELZ · Class 1—Lister—2017
Zinc Oxide EugenolEMB · Class 1Dental cementsLister—2024
Surgical HemostatEMD · Class 1Dental hand instrumentsLister—2024
Surgical Tooth Extractor ForcepsEMG · Class 1Dental hand instrumentsLister—2023
Surgical Rongeur ForcepsEMH · Class 1Dental hand instrumentsLister—2025
Dental Surgical ElevatorEMJ · Class 1Dental hand instrumentsLister—2024
Periodontic ScalerEMN · Class 1Dental hand instrumentsLister—2017
Periodontic FileEMR · Class 1Dental hand instrumentsLister—2024
Periodontic CuretteEMS · Class 1Dental hand instrumentsLister—2017
Matrix RetainerJEP · Class 1Dental hand instrumentsLister—2021
Powered ToothbrushJEQ · Class 1ToothbrushesLister—2018
Mechanical Denture CleanerJER · Class 1Denture cleansers & adhesivesLister—2026
Dental FlossJES · Class 1Floss & interdental cleanersLister—2024
Orthodontic PlierJEX · Class 1Dental hand instrumentsLister—2018
Tube Impression and MatrixKCQ · Class 1—Lister—2025
AirbrushKOJ · Class 2—Lister—2018
Resin ApplicatorKXR · Class 1—Lister—2017
Digital Extraoral Source X-Ray SystemMUH · Class 2Dental X-ray unitsLister—2020
Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering for Pain ReliefMZW · Class 2—Lister—2024
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsLister—2018
Accessories Operative Dental UnitNRD · Class 1—Lister—2019
Dental Abutment Design Software for Dental LaboratoryPNP · Class 2Dental design & orthodontic softwareLister—2026
Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2Denture resins & teethLister—2026

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

Also lists devices cleared under other names

Mainline Medical Dental Supply lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: GC America Inc. (36), Sybron Dental Specialties (34), Dentsply Intl., Inc. (31), 3M Company (15), Coltene/Whaledent AG (15), Ivoclar Vivadent, AG (12), Heraeus Kulzer, LLC (12), Parkell, Inc (11).

Decided510(k)DeviceApplicantDevice type
7 May 2024K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona, Inc.NHA Endosseous Dental Implant Abutment
20 Oct 2023K231578Lucitone Digital Print Denture SystemDentsply Sirona, Inc.EBI Rebasing Repairing Relining Denture Resin
28 Oct 2022K222583Stela Capsule SystemSdi LimitedEBF Resin Tooth Shade Material
30 Aug 2022K214118Riva Cem AutomixSdi LimitedEMA Dental Cement
8 Oct 2019K191133KATANA Cleaner, KATANA Cleaner (Trial)Kuraray Noritake Dental, Inc.PME External Cleaning Solution
26 Aug 2019K191427Halley resin systemDentsply Sirona, Inc.EBI Rebasing Repairing Relining Denture Resin
11 Jul 2019K182854GC FujiCEM 2 (Improved)GC America Inc.EMA Dental Cement
2 Jan 2019K1834763M Filtek Universal Restorative3M Espe Dental ProductsEBF Resin Tooth Shade Material
20 Nov 2018K182288TPH Spectra ST Flowable Composite RestorativeDentsply Sirona, Inc.EBF Resin Tooth Shade Material
28 Sep 2018K181476Prime&Bond active Universal AdhesiveDentsply Sirona, Inc.KLE Resin Tooth Bonding Agent
22 Aug 2018K181312GrandioSO x-traVoco GmbHEBF Resin Tooth Shade Material
8 Mar 2018K173500NMF004AGC America Inc.EBF Resin Tooth Shade Material
27 Feb 2018K173275OMNICHROMATokuyama Dental CorporationEBF Resin Tooth Shade Material
18 Jul 2017K171844Inspire ICE aka Inspire ICE Clear BracketsSybron Dental SpecialtiesNJM Orthodontic Ceramic Bracket
6 Feb 2017K1703303M Protemp Cement Temporary Dental Cement3M CompanyEMA Dental Cement
28 Nov 2016K163207Filtek One Bulk Fill Restorative3M CompanyEBF Resin Tooth Shade Material
15 Nov 2016K160049CharismaHeraeus Kulzer, LLC (Mitsui Chemicals Group)EBF Resin Tooth Shade Material
7 Nov 2016K162257P1145 Dental RestorativeSybron Dental SpecialtiesEBF Resin Tooth Shade Material
25 Oct 2016K161042CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value packKuraray Noritake Dental, Inc.KLE Resin Tooth Bonding Agent
27 Sep 2016K162107TPH Spectra+ Universal Composite RestorativeDentsply Sirona, Inc.EBF Resin Tooth Shade Material
27 Sep 2016K160825MIDWEST RDH Freedom Cordless Prophy System with SmartMode TechnologyDentsply Sirona, Inc.EKX Ac-Powered Direct Drive Handpiece
27 Jul 2016K160596BEAUTIFIL II LSShofu IncEBF Resin Tooth Shade Material
27 Jul 2016K153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressSybron Dental SpecialtiesKIF Root Canal Filling Resin
14 Apr 2016K152959Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesSybron Dental SpecialtiesKIF Root Canal Filling Resin
13 Apr 2016K153174Ketac Universal Aplicap3M Deutschland GmbHEMA Dental Cement
4 Mar 2016K152861Aquasil Ultra + Smart Wetting Impression MaterialDentply International, Inc.ELW Impression Material
9 Dec 2015K152243One Coat 7 UniversalColtene/Whaledent AGKLE Resin Tooth Bonding Agent
30 Oct 2015K151619Prime&Bond Elect Universal Dental AdhesiveDentsply International, Inc.KLE Resin Tooth Bonding Agent
18 Sep 2015K151518BRUSH&BOND PLUSParkell, IncKLE Resin Tooth Bonding Agent
28 Aug 2015K151088DMRC Bulk FillDanville Materials, LLCEBF Resin Tooth Shade Material
21 Aug 2015K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth PrimerKuraray Noritake Dental, Inc.EMA Dental Cement
17 Aug 2015K151332Nexus Universal, Nexus Universal ChromaSybron Dental SpecialtiesEMA Dental Cement
31 Jul 2015K151053PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scannerSopro - Acteon GroupMUH Digital Extraoral Source X-Ray System
7 Jul 2015K150933iBond Universal & iBond Ceramic PrimerHeraeus Kulzer, LLC (Mitsui Chemicals Group)KLE Resin Tooth Bonding Agent
23 Jun 2015K150218Fill-Up!Coltene/Whaledent AGEBF Resin Tooth Shade Material
16 Jun 2015K150535Cavitron Touch Ultrasonic Scaling SystemDentsply International, Inc.ELC Ultrasonic Scaler
25 Nov 2014K142389Variolink EstheticIvoclar Vivadent, AGEBF Resin Tooth Shade Material
8 Jul 2014K140144BENDA WEDGECentrix, Inc.EJB Dental Instrument Handle
8 May 2014K141081FILTEK BULK FILL POSTERIOR RESTROATIVE3M Espe Dental ProductsEBF Resin Tooth Shade Material
14 Mar 2014K133824CERASMARTGC America Inc.EBF Resin Tooth Shade Material
11 Mar 2014K132322NEWTRON P5 XS B.LEDSatelec - Acteon GroupELC Ultrasonic Scaler
6 Mar 2014K133836OPTIGLAZE COLORGC America Inc.EBD Resin Filling Material Coating
11 Feb 2014K133318ADHESE UNIVERSALIvoclar Vivadent, AGKLE Resin Tooth Bonding Agent
31 Oct 2013K132209IPS E.MAX CAD ABUTMENT SOLUTIONSIvoclar Vivadent, AGNHA Endosseous Dental Implant Abutment
27 Sep 2013K130560MASTERTORQUE LUX 8900 LKaltenbach & Voigt GmbHEFB Dental Air-Powered Handpiece
20 Jun 2013K130486FUTURABOND UNIVERSALVoco GmbHKLE Resin Tooth Bonding Agent
17 May 2013K130647XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50MLHeraeus Kulzer, LLCELW Impression Material
22 Feb 2013K123615IRIS - HIGH STRENGTH GLASS CERAMICDentsply Intl., Inc.EIH Porcelain Powder
1 Feb 2013K123545INCORIS TZIDentsply Sirona, Inc.EIH Porcelain Powder
31 Jan 2013K123397MULTILINK AUTOMIXIvoclar Vivadent, AGEBF Resin Tooth Shade Material
8 Jan 2013K121621SOLOCEMColtene/Whaledent AGEMA Dental Cement
7 Dec 2012K123278IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELFHeraeus Kulzer, LLCKLE Resin Tooth Bonding Agent
27 Nov 2012K121093D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000Dxm Co., Ltd.EBZ Ultraviolet Activator for Polymerization
25 Sep 2012K121880DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUIDDanville Materials, LLCEBF Resin Tooth Shade Material
23 Aug 2012K121824ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2Lascod SpaELW Impression Material
9 Aug 2012K121524INSIGNIASybron Dental SpecialtiesDYW Orthodontic Plastic Bracket
13 Jul 2012K113574FLEXITIME MONOPHASE PRO SCANHeraeus Kulzer, LLCELW Impression Material
27 Jun 2012K120243GAM-200GC America Inc.EMA Dental Cement
10 May 2012K120521GC BLUE SILICONEGC America Inc.ELW Impression Material
2 May 2012K120438FLASH (DIFFERENT MATERIALS)3M Deutschland GmbHELW Impression Material
5 Apr 2012K120003NUCALPulpdent CorporationEJK Calcium Hydroxide Cavity Liner
30 Mar 2012K120379PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA SKuraray Medical, Inc.EMA Dental Cement
23 Feb 2012K113430PROULTRA PIEZO ULTRASONICSatelec - Acteon GroupELC Ultrasonic Scaler
14 Dec 2011K112501VENUS PEARL PLT REFILL A1Heraeus Kulzer, LLCEBF Resin Tooth Shade Material
14 Oct 2011K111980CLEARFIL TRI-S BOND PLUSKuraray America, Inc.KLE Resin Tooth Bonding Agent
21 Sep 2011K111876Z BOND, PRELUDE ONEDanville Materials, LLCKLE Resin Tooth Bonding Agent
29 Aug 2011K110756BLUEPHASE STYLEIvoclar Vivadent, AGEBZ Ultraviolet Activator for Polymerization
17 Jun 2011K110871FIT CHECKER ADVANCEDGC America Inc.ELW Impression Material
5 May 2011K111185RELYX LUTING PLUS AUTOMIX3M Espe Dental ProductsEMA Dental Cement
25 Feb 2011K103528IPS EMPRESS DIRECT FLOWIvoclar Vivadent, AGEBF Resin Tooth Shade Material
14 Feb 2011K103379TELIO CS INLAY & TELIO CS ONLAYIvoclar Vivadent, AGEBG Resin Temporary Crown and Bridge
4 Feb 2011K102753TURBO TEMP 3Danville Materials, LLCEBG Resin Temporary Crown and Bridge
20 Jan 2011K103351DMC COMPOSITE 2Sybron Dental SpecialtiesEBF Resin Tooth Shade Material
8 Dec 2010K102984AURASdi LimitedEBF Resin Tooth Shade Material
2 Nov 2010K102351GRANDIO SOVoco GmbHEBF Resin Tooth Shade Material
29 Oct 2010K101504TI-CORE FLOWEssential Dental Systems, Inc.EMA Dental Cement
23 Aug 2010K101603BEAUTIFIL FLOW PLUSShofu IncEBF Resin Tooth Shade Material
10 Jun 2010K101044RETRIEVE IMPLANT CEMENTParkell, IncEMA Dental Cement
12 May 2010K100235FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE3M CompanyEBF Resin Tooth Shade Material
8 Apr 2010K094007UNICEM3M Espe AG Dental ProductsEMA Dental Cement
10 Mar 2010K093744EXCITE F AND EXCITE DSCIvoclar Vivadent, AGKLE Resin Tooth Bonding Agent
10 Mar 2010K093708TELIO CADIvoclar Vivadent, AGEBG Resin Temporary Crown and Bridge
16 Dec 2009K092912STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150Danville Materials, LLCEBF Resin Tooth Shade Material
14 Oct 2009K091091SONICFILL 2010Sybron Dental SpecialtiesEBF Resin Tooth Shade Material
7 Oct 2009K091613TAKE 1Sybron Dental SpecialtiesELW Impression Material
16 Sep 2009K092319STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387Danville Materials, LLCELW Impression Material
3 Sep 2009K091635VENUS DIAMOND FLOWHeraeus Kulzer, LLCEBF Resin Tooth Shade Material
31 Jul 2009K091494FLEXITIME FLOWHeraeus Kulzer, LLCELW Impression Material
22 Jul 2009K091388GCUC-505GC America Inc.EBF Resin Tooth Shade Material
10 Jun 2009K090747MI FLOW (GCUC-450)GC America Inc.EBF Resin Tooth Shade Material
5 Jun 2009K083195MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESINLang Dental Mfg. Co., Inc.EBG Resin Temporary Crown and Bridge
11 May 2009K090826MONOBOND PLUSIvoclar Vivadent, AGKLE Resin Tooth Bonding Agent
31 Mar 2009K090106PRELUDE ONEDanville Materials, LLCKLE Resin Tooth Bonding Agent
9 Mar 2009K083796MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHTMiltex, Inc.EJI Cartridge Syringe
10 Feb 2009K083326FLUOROCORE 2Dentsply International, Inc.EBF Resin Tooth Shade Material
21 Jan 2009K083652IBOND TOTAL ETCHHeraeus Kulzer, LLCKLE Resin Tooth Bonding Agent
17 Dec 2008K083610FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE3M CompanyEBF Resin Tooth Shade Material
24 Sep 2008K081415DAMON 4CLEARSybron Dental SpecialtiesNJM Orthodontic Ceramic Bracket
20 Jun 2008K080687SMARTBURSSS White Burs LLCEJL Dental Bur
19 Jun 2008K080940ESTELITE SIGMA QUICKTokuyama Dental CorporationEBF Resin Tooth Shade Material
29 Jan 2008K073209MAXCEM 2Sybron Dental SpecialtiesMZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering for Pain Relief
16 Nov 2007K072604DUO TEMPColtene/Whaledent AGEMA Dental Cement
5 Nov 2007K072580JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23Lang Dental Mfg. Co., Inc.EBI Rebasing Repairing Relining Denture Resin
15 Aug 2007K071742BEAUTIFIL IIShofu IncEBF Resin Tooth Shade Material
19 Jul 2007K071288MODIFICATION TO KAVO QUATTROCARESybron Dental SpecialtiesEBF Resin Tooth Shade Material
7 Jun 2007K070723FUTURABOND DC/SINGLE DOSEVoco GmbHKLE Resin Tooth Bonding Agent
29 Mar 2007K070697COE SOFTGC America Inc.EBI Rebasing Repairing Relining Denture Resin
29 Mar 2007K070698COE COMFORTGC America Inc.EBI Rebasing Repairing Relining Denture Resin
12 Mar 2007K070190GRADIA DIRECT XGC America Inc.EBF Resin Tooth Shade Material
26 Feb 2007K070319GC FUJI IX GP EXTRAGC America Inc.EMA Dental Cement
2 Feb 2007K063593CLEARFIL MAJESTY FLOWKuraray America, Inc.EBF Resin Tooth Shade Material
21 Nov 2006K062166ENAMEL PROPremier Dental Products CompanyEJR Oral Cavity Abrasive Polishing Agent
15 Nov 2006K062065RIVA LUTING PLUSSouthern Dental Industries, Inc.EMA Dental Cement
25 Oct 2006K062292UNICEM3M Espe Dental ProductsEMA Dental Cement
19 Oct 2006K062519NEXUS 3Sybron Dental SpecialtiesEMA Dental Cement
24 Apr 2006K060684ADPER PROMPT, ADPER PROMPT L-POP3M Espe AG Dental ProductsKLE Resin Tooth Bonding Agent
3 Feb 2006K053565TEMPBOND CLEAR WITH TRICLOSANSybron Dental SpecialtiesEMA Dental Cement
9 Jan 2006K052820PARAPOST PARACORE AUTOMIX 5MLColtene/Whaledent AGEBF Resin Tooth Shade Material
30 Nov 2005K052477DAMON 3 MODIFIEDSybron Dental SpecialtiesDYW Orthodontic Plastic Bracket
9 Nov 2005K053040PARACEM UNIVERSAL DCColtene/Whaledent AGEMA Dental Cement

Showing the 120 most recent of 340.

Registered establishments

EstablishmentLocationWhat it does
MAINLINE MEDICAL DENTAL SUPPLYFDA reg. 3012421607North York Ontario, CanadaForeign exporter

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10052656). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.