Registered with FDA
Samtrade Supplies Inc.
TORONTO, Canada. Lists 27 dental device types with FDA across 1 registered establishment.
- Device types listed
- 27
- Brands and models
- 86
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Canada
Devices listed with FDA
What Samtrade Supplies Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Impression MaterialELW · Class 2 | Impression materials | Lister | Aquasil HeavyAquasil PuttyAquasil RigidDimension PentaExpress PuttyExtrude ImpressionFlexitime Impression MaterialImpregum FImpregum PentaImprint 3 Heavy Body 4 morePermlastic ImpressionPolyether TrayRegisil ImpressionReprosil Impression Material | 2017 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | Beautifil FlowCharisma CompositesEsthetX HDFiltek Z350XT CompositeGrandi Syr/CapsPremise FlowRevolutionSonicfill CompositeStar Flow SyringesTPH Composites 3 moreUltra EtchVertise FlowXRV Herculite Composites | 2017 |
| Dental CementEMA · Class 2 | Dental cements | Lister | EquiaFuji CapsulesFuji CemFuji IKetac Cem Radiopaque KitMaxcemNX3 CementProtmep / Durelon CementRelyx Luting kit / ClickerRelyx Unicem , Relyx U200, Relyx Automix 3 moreRelyx VeneerTempbond clearVitrebond | 2017 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | Adper L PopCavity ConditionerClearfil BondG-BondGluma Bond/DesensitizerIBond Bonding BottleOptibond Solo Plus / Optibond SPreludePrime & Bond NTScotchbond/Singlebond Bottle | 2017 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | CavitIntegrity C & B MaterialLuxatemp C & B MaterialProtempTurbotemp | 2017 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Lister | AH Plus / 26Pulp Canal / EWTSealapexTubliseal / EWT | 2020 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Lister | Clinpro SyringeSonicfill CompositeVertise Flow | 2019 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Lister | Coe ComfortCoe SoftReline kit / Soft | 2017 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Lister | Fuji Ortho kitTransbond | 2020 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | AutomatrixPalodent Matrices | 2019 |
| Amalgam Dental CapsuleDZS · Class 1 | — | Lister | Tytin Amalgam | 2018 |
| Pulp TesterEAT · Class 2 | — | Lister | Endo Ice | 2020 |
| Resin Filling Material CoatingEBD · Class 2 | — | Lister | Dycal Ivory | 2020 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Lister | Stabilok | 2024 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Lister | Kavo Spray | 2019 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Lister | Soflex / Enhance polishing | 2017 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | Tray Adhesive | 2020 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Lister | Rubber Dam | 2020 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Lister | IPS CEREC BLOCKS | 2017 |
| Amalgam AlloyEJJ · Class 2 | — | Lister | Tytin Amalgam | 2018 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Lister | Nupro Paste | 2022 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Lister | Cavitron | 2024 |
| MercuryELY · Class 2 | — | Lister | Tytin Amalgam | 2018 |
| Preformed CrownELZ · Class 1 | — | Lister | Kids Crowms | 2017 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Lister | IRM / Zoe Cement | 2017 |
| Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering for Pain ReliefMZW · Class 2 | — | Lister | Maxcem | 2017 |
| Resin Long-Term Temporary Crown and BridgePOW · Class 2 | — | Lister | Turbotemp | 2024 |
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
Samtrade Supplies Inc. 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: Sybron Dental Specialties (14), Dentsply Intl., Inc. (12), GC America Inc. (10), 3M Company (8), Heraeus Kulzer, LLC (3), 3M Espe AG Dental Products (3), Danville Materials, LLC (2), Dentsply International, Inc. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Sep 2019 | K191619 | TurboTemp EZ | Zest Anchors, LLC | EBG Resin Temporary Crown and Bridge |
| 6 Feb 2017 | K170330 | 3M Protemp Cement Temporary Dental Cement | 3M Company | EMA Dental Cement |
| 15 Nov 2016 | K160049 | Charisma | Heraeus Kulzer, LLC (Mitsui Chemicals Group) | EBF Resin Tooth Shade Material |
| 27 Sep 2016 | K162107 | TPH Spectra+ Universal Composite Restorative | Dentsply Sirona, Inc. | EBF Resin Tooth Shade Material |
| 27 Jul 2016 | K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress | Sybron Dental Specialties | KIF Root Canal Filling Resin |
| 6 May 2016 | K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWT | Sybron Dental Specialties | KIF Root Canal Filling Resin |
| 14 Apr 2016 | K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes | Sybron Dental Specialties | KIF Root Canal Filling Resin |
| 5 Feb 2015 | K143209 | SonicFill 2 | Sybron Dental Specialties | EBF Resin Tooth Shade Material |
| 7 Dec 2012 | K123278 | IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF | Heraeus Kulzer, LLC | KLE Resin Tooth Bonding Agent |
| 5 May 2011 | K111185 | RELYX LUTING PLUS AUTOMIX | 3M Espe Dental Products | EMA Dental Cement |
| 20 Jan 2011 | K103351 | DMC COMPOSITE 2 | Sybron Dental Specialties | EBF Resin Tooth Shade Material |
| 2 Nov 2010 | K102351 | GRANDIO SO | Voco GmbH | EBF Resin Tooth Shade Material |
| 23 Aug 2010 | K101603 | BEAUTIFIL FLOW PLUS | Shofu Inc | EBF Resin Tooth Shade Material |
| 8 Apr 2010 | K094007 | UNICEM | 3M Espe AG Dental Products | EMA Dental Cement |
| 27 Jan 2010 | K093484 | PREMISE FLOWABLE MODIFIED | Sybron Dental Specialties | EBF Resin Tooth Shade Material |
| 31 Jul 2009 | K091494 | FLEXITIME FLOW | Heraeus Kulzer, LLC | ELW Impression Material |
| 17 Jun 2009 | K091106 | EQUIA | GC America Inc. | EMA Dental Cement |
| 31 Mar 2009 | K090106 | PRELUDE ONE | Danville Materials, LLC | KLE Resin Tooth Bonding Agent |
| 17 Dec 2008 | K083610 | FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE | 3M Company | EBF Resin Tooth Shade Material |
| 11 Dec 2008 | K082671 | HERCULITE ULTRA | Sybron Dental Specialties | EBF Resin Tooth Shade Material |
| 21 Oct 2008 | K082768 | G-BOND PLUS | GC America Inc. | KLE Resin Tooth Bonding Agent |
| 29 Jan 2008 | K073209 | MAXCEM 2 | Sybron Dental Specialties | MZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering for Pain Relief |
| 29 Mar 2007 | K070698 | COE COMFORT | GC America Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 29 Mar 2007 | K070697 | COE SOFT | GC America Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 19 Oct 2006 | K062519 | NEXUS 3 | Sybron Dental Specialties | EMA Dental Cement |
| 24 Apr 2006 | K060684 | ADPER PROMPT, ADPER PROMPT L-POP | 3M Espe AG Dental Products | KLE Resin Tooth Bonding Agent |
| 17 Feb 2006 | K060293 | TEMPORARY CROWN AND BRIDGE MATERIAL | Dentsply International, Inc. | EBG Resin Temporary Crown and Bridge |
| 3 Feb 2006 | K053565 | TEMPBOND CLEAR WITH TRICLOSAN | Sybron Dental Specialties | EMA Dental Cement |
| 14 Oct 2005 | K051705 | IPS E.MAX CAD/IPS E.MAX ZIRCAD | Ivoclar Vivadent, AG | EIH Porcelain Powder |
| 23 Feb 2005 | K050386 | PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM | Dentsply International, Inc. | KLE Resin Tooth Bonding Agent |
| 21 Nov 2003 | K033022 | PROTEMP 3 GARANT | 3M Espe AG Dental Products | EBG Resin Temporary Crown and Bridge |
| 26 Jun 2002 | K012308 | KAVO QUATTROCARE | Kavo America | EFB Dental Air-Powered Handpiece |
| 13 May 2002 | K021416 | AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL | Dentsply Intl., Inc. | ELW Impression Material |
| 10 May 2002 | K021413 | AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL | Dentsply Intl., Inc. | ELW Impression Material |
| 3 May 2002 | K020760 | STARFLOW HV | Danville Materials, LLC | EBF Resin Tooth Shade Material |
| 24 Jan 2002 | K013674 | LUXATEMP/LUXATEMP SOLAR/INSTATEMP | Dmg USA, Inc. | EBG Resin Temporary Crown and Bridge |
| 16 Jan 2002 | K013647 | REVOLUTION FORMULA 2 | Sybron Dental Specialties | EBF Resin Tooth Shade Material |
| 29 Oct 2001 | K013198 | FUJI VII CAPSULE | GC America Inc. | EMA Dental Cement |
| 10 Sep 2001 | K012442 | MODIFICATION TO CLEARFIL SE BOND | Kuraray Medical, Inc. | KLE Resin Tooth Bonding Agent |
| 4 Sep 2001 | K012405 | EXTRUDE MODIFIED | Sybron Dental Specialties | ELW Impression Material |
| 28 Sep 2000 | K002452 | 3M RELY X VENEER CEMENT TRY-IN PASTER | 3M Company | EMA Dental Cement |
| 10 Aug 2000 | K001655 | PERMLASTIC 2 | Sybron Dental Specialties | ELW Impression Material |
| 17 Jul 2000 | K001730 | GC FUJICEM | GC America Inc. | EMA Dental Cement |
| 24 Mar 2000 | K000169 | NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN | Dentsply Intl., Inc. | EJR Oral Cavity Abrasive Polishing Agent |
| 14 Oct 1999 | K992985 | GLUMA COMFORT BOND | Heraeus Kulzer, LLC | KLE Resin Tooth Bonding Agent |
| 8 Oct 1999 | K992326 | 3M CLINPRO SEALANT | 3M Company | EBC Pit and Fissure Sealant and Conditioner |
| 8 Sep 1999 | K992895 | IMPREGUM F | Espe Dental AG | ELW Impression Material |
| 8 Sep 1999 | K992897 | IMPREGUM PENTA | Espe Dental AG | ELW Impression Material |
| 8 Mar 1999 | K990498 | OPTIBOND SOLO PLUS | Sybron Dental Specialties | KLE Resin Tooth Bonding Agent |
| 13 Jan 1999 | K984387 | R-30 AESTHETIC RESTORATIVE | Dentsply Intl., Inc. | EBF Resin Tooth Shade Material |
| 13 Apr 1998 | K980695 | FUJI I | GC America Inc. | EMA Dental Cement |
| 11 Dec 1997 | K973781 | AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL | Dentsply Intl., Inc. | ELW Impression Material |
| 11 Apr 1997 | K970123 | DENTSPLY CAVITRON SPS SCALER SYSTEM | Dentsply Intl., Inc. | ELC Ultrasonic Scaler |
| 29 Oct 1996 | K963144 | GC BASELINE | GC America Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 18 Jul 1996 | K962065 | 3M VITREBOND LIGHT CURE GLASS IONOMER/BASE | 3M Company | EMA Dental Cement |
| 26 Apr 1996 | K960548 | AH PLUS ROOT CANAL SEALER | Dentsply Intl., Inc. | KIF Root Canal Filling Resin |
| 15 Mar 1996 | K960547 | DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE | Espe GmbH & Co. Kg. | ELW Impression Material |
| 27 Sep 1995 | K953166 | FUJI BOND LC | GC America Inc. | KLE Resin Tooth Bonding Agent |
| 8 Mar 1995 | K950556 | FUJI ORTHO LC | GC America Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 11 Mar 1994 | K935535 | TYTIN | Kerr Corporation (Danbury) | EJJ Amalgam Alloy |
| 9 Sep 1993 | K931867 | ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE | Ultradent Products, Inc. | EBF Resin Tooth Shade Material |
| 27 May 1993 | K930764 | ENDO-ICE-PULP TESTER-THERMAL | The Hygenic Company, LLC | EAT Pulp Tester |
| 11 Aug 1988 | K882690 | IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL | 3M Company | ELW Impression Material |
| 31 Mar 1988 | K880393 | TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE | Unitek Corp. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 1 Mar 1988 | K875133 | CAVIT-W | Espe GmbH (Us) | EBG Resin Temporary Crown and Bridge |
| 1 Dec 1986 | K863288 | HYDROPHILIC REPROSIL | Dentsply Intl., Inc. | ELW Impression Material |
| 25 Mar 1985 | K844846 | ESPE KETAC-CEM RADIOPAQUE | Espe GmbH (Us) | EMA Dental Cement |
| 18 Mar 1985 | K850641 | CAULK DYCAL LIGHT CURED | Dentsply Intl., Inc. | EBD Resin Filling Material Coating |
| 16 Aug 1982 | K822094 | DENTAL MATRIX BAND | Dentsply Intl., Inc. | DZN Dental Hand Instruments |
| 12 Jan 1982 | K813180 | SCOTCHBOND DENTAL ADHESIVE | 3M Company | KLE Resin Tooth Bonding Agent |
| 7 Aug 1980 | K801142 | PALODENT MATRICES & BITINE RINGS | Alvin Meyer, D.D.S. | DZN Dental Hand Instruments |
| 21 Jul 1980 | K801548 | PERF-LOCK IMPRESSION TRAY | Dentsply Intl., Inc. | EHY Preformed Impression Tray |
| 18 Mar 1980 | K800485 | VINYL POLYSILOXANE IMPRESSION MATERIAL | 3M Company | ELW Impression Material |
| 5 Feb 1980 | K800031 | PERMADYNE POLYETHER RUBBER IMPRESSION | Espe Dental Products | ELW Impression Material |
| 31 Aug 1978 | K781151 | REPROSIL | Dentsply Intl., Inc. | ELW Impression Material |
| 12 May 1978 | K780745 | RUBBER DAM | Hygienic Dental Mfg., Co., The | EIE Rubber Dam |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SAMTRADE SUPPLIES INC.FDA reg. 3008912871 | TORONTO Ontario, Canada | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10056140). 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.