Data / Medical devices / Canada / Samtrade Supplies Inc.
Samtrade Supplies Inc.: FDA-registered device maker in TORONTO Ontario, Canada, 79 510(k) clearances
Samtrade Supplies Inc. is registered with the FDA (registration 3008912871) in TORONTO Ontario, Canada. It lists 32 device types. The FDA files 79 510(k) clearances under its listings, the newest dated September 11, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008912871
- Address
- 75 Baycrest Ave. #2, TORONTO Ontario, Canada, M6A1W2
- Owner or operator
- SAMTRADE SUPPLIES INC. (10056140)
- Roles
- Exporter to the US
- First device listed
- November 8, 2017
- Registered through
- 2026
- Brand names listed
- 3M Masks, AH Plus / 26, Adper L Pop, Aquasil Heavy, Aquasil Putty, Aquasil Rigid, Automatrix, Beautifil Flow and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 11, 2019 | K191619 | TurboTemp EZ | EBG | Substantially Equivalent | Zest Anchors, LLC | accessdata.fda.gov |
| September 11, 2019 | K191355 | 3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask | FXX | Substantially Equivalent | 3M Healthcare | accessdata.fda.gov |
| February 6, 2017 | K170330 | 3M Protemp Cement Temporary Dental Cement | EMA | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| November 15, 2016 | K160049 | Charisma | EBF | Substantially Equivalent | Heraeus Kulzer, LLC (Mitsui Chemicals Group) | accessdata.fda.gov |
| September 27, 2016 | K162107 | TPH Spectra+ Universal Composite Restorative | EBF | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| July 27, 2016 | K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress | KIF | Substantially Equivalent | Sybron Dental Specialties | accessdata.fda.gov |
| May 6, 2016 | K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWT | KIF | Substantially Equivalent | Sybron Dental Specialties | accessdata.fda.gov |
| April 14, 2016 | K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes | KIF | Substantially Equivalent | Sybron Dental Specialties | accessdata.fda.gov |
| February 5, 2015 | K143209 | SonicFill 2 | EBF | Substantially Equivalent | Sybron Dental Specialties | accessdata.fda.gov |
| February 5, 2013 | K123215 | VISCOSTAT CLEAR | MVL | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| December 7, 2012 | K123278 | IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF | KLE | Substantially Equivalent | Heraeus Kulzer, LLC | accessdata.fda.gov |
| May 5, 2011 | K111185 | RELYX LUTING PLUS AUTOMIX | EMA | Substantially Equivalent | 3M Espe Dental Products | accessdata.fda.gov |
| January 20, 2011 | K103351 | DMC COMPOSITE 2 | EBF | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| November 2, 2010 | K102351 | GRANDIO SO | EBF | Substantially Equivalent | Voco GmbH | accessdata.fda.gov |
| August 23, 2010 | K101603 | BEAUTIFIL FLOW PLUS | EBF | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| April 8, 2010 | K094007 | UNICEM | EMA | Substantially Equivalent | 3M Espe AG Dental Products | accessdata.fda.gov |
| January 27, 2010 | K093484 | PREMISE FLOWABLE MODIFIED | EBF | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| July 31, 2009 | K091494 | FLEXITIME FLOW | ELW | Substantially Equivalent | Heraeus Kulzer, Inc. | accessdata.fda.gov |
| June 17, 2009 | K091106 | EQUIA | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| March 31, 2009 | K090106 | PRELUDE ONE | KLE | Substantially Equivalent | Danville Materials, Inc. | accessdata.fda.gov |
| December 17, 2008 | K083610 | FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE | EBF | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| December 11, 2008 | K082671 | HERCULITE ULTRA | EBF | Substantially Equivalent | Sybron Dental Specialties | accessdata.fda.gov |
| October 21, 2008 | K082768 | G-BOND PLUS | KLE | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| January 29, 2008 | K073209 | MAXCEM 2 | MZW | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| March 29, 2007 | K070698 | COE COMFORT | EBI | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| March 29, 2007 | K070697 | COE SOFT | EBI | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| October 19, 2006 | K062519 | NEXUS 3 | EMA | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| April 24, 2006 | K060684 | ADPER PROMPT, ADPER PROMPT L-POP | KLE | Substantially Equivalent | 3M Espe AG Dental Products | accessdata.fda.gov |
| February 17, 2006 | K060293 | TEMPORARY CROWN AND BRIDGE MATERIAL | EBG | Substantially Equivalent | Dentsply International, Inc. | accessdata.fda.gov |
| February 3, 2006 | K053565 | TEMPBOND CLEAR WITH TRICLOSAN | EMA | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| October 14, 2005 | K051705 | IPS E.MAX CAD/IPS E.MAX ZIRCAD | EIH | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| February 23, 2005 | K050386 | PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM | KLE | Substantially Equivalent | Dentsply International | accessdata.fda.gov |
| November 21, 2003 | K033022 | PROTEMP 3 GARANT | EBG | Substantially Equivalent | 3M Espe AG Dental Products | accessdata.fda.gov |
| June 26, 2002 | K012308 | KAVO QUATTROCARE | EFB | Substantially Equivalent | Kavo America | accessdata.fda.gov |
| May 13, 2002 | K021416 | AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL | ELW | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| May 10, 2002 | K021413 | AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL | ELW | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| May 3, 2002 | K020760 | STARFLOW HV | EBF | Substantially Equivalent | Danville Materials, Inc. | accessdata.fda.gov |
| January 24, 2002 | K013674 | LUXATEMP/LUXATEMP SOLAR/INSTATEMP | EBG | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| January 16, 2002 | K013647 | REVOLUTION FORMULA 2 | EBF | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| October 29, 2001 | K013198 | FUJI VII CAPSULE | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| September 10, 2001 | K012442 | MODIFICATION TO CLEARFIL SE BOND | KLE | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| September 4, 2001 | K012405 | EXTRUDE MODIFIED | ELW | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| September 28, 2000 | K002452 | 3M RELY X VENEER CEMENT TRY-IN PASTER | EMA | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| August 10, 2000 | K001655 | PERMLASTIC 2 | ELW | Substantially Equivalent | Kerr Corp. | accessdata.fda.gov |
| July 17, 2000 | K001730 | GC FUJICEM | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| March 24, 2000 | K000169 | NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN | EJR | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| October 14, 1999 | K992985 | GLUMA COMFORT BOND | KLE | Substantially Equivalent | Heraeus Kulzer, Inc. | accessdata.fda.gov |
| October 8, 1999 | K992326 | 3M CLINPRO SEALANT | EBC | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| September 8, 1999 | K992897 | IMPREGUM PENTA | ELW | Substantially Equivalent | Espe Dental AG | accessdata.fda.gov |
| September 8, 1999 | K992895 | IMPREGUM F | ELW | Substantially Equivalent | Espe Dental AG | accessdata.fda.gov |
| March 8, 1999 | K990498 | OPTIBOND SOLO PLUS | KLE | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
| January 13, 1999 | K984387 | R-30 AESTHETIC RESTORATIVE | EBF | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| April 13, 1998 | K980695 | FUJI I | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| December 11, 1997 | K973781 | AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL | ELW | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| April 11, 1997 | K970123 | DENTSPLY CAVITRON SPS SCALER SYSTEM | ELC | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| October 29, 1996 | K963144 | GC BASELINE | EBI | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| July 18, 1996 | K962065 | 3M VITREBOND LIGHT CURE GLASS IONOMER/BASE | EMA | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| April 26, 1996 | K960548 | AH PLUS ROOT CANAL SEALER | KIF | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| March 15, 1996 | K960547 | DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE | ELW | Substantially Equivalent | Espe GmbH & Co. Kg. | accessdata.fda.gov |
| September 27, 1995 | K953166 | FUJI BOND LC | KLE | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| March 8, 1995 | K950556 | FUJI ORTHO LC | DYH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| March 11, 1994 | K935535 | TYTIN | EJJ | Substantially Equivalent | Kerr Corporation (Danbury) | accessdata.fda.gov |
| September 9, 1993 | K931867 | ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE | EBF | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| May 27, 1993 | K930764 | ENDO-ICE-PULP TESTER-THERMAL | EAT | Substantially Equivalent | The Hygenic Corp. | accessdata.fda.gov |
| May 31, 1990 | K896554 | GUT SUTURES | GAL | Substantially Equivalent for Some Indications | Look, Inc. | accessdata.fda.gov |
| August 11, 1988 | K882690 | IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL | ELW | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| March 31, 1988 | K880393 | TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE | DYH | Substantially Equivalent | Unitek Corp. | accessdata.fda.gov |
| March 1, 1988 | K875133 | CAVIT-W | EBG | Substantially Equivalent | Espe GmbH (Us) | accessdata.fda.gov |
| December 1, 1986 | K863288 | HYDROPHILIC REPROSIL | ELW | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| March 25, 1985 | K844846 | ESPE KETAC-CEM RADIOPAQUE | EMA | Substantially Equivalent | Espe GmbH (Us) | accessdata.fda.gov |
| March 18, 1985 | K850641 | CAULK DYCAL LIGHT CURED | EBD | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| August 16, 1982 | K822094 | DENTAL MATRIX BAND | DZN | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| January 12, 1982 | K813180 | SCOTCHBOND DENTAL ADHESIVE | KLE | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| August 7, 1980 | K801142 | PALODENT MATRICES & BITINE RINGS | DZN | Substantially Equivalent | Alvin Meyer, D.D.S. | accessdata.fda.gov |
| July 21, 1980 | K801548 | PERF-LOCK IMPRESSION TRAY | EHY | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| March 18, 1980 | K800485 | VINYL POLYSILOXANE IMPRESSION MATERIAL | ELW | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| February 5, 1980 | K800031 | PERMADYNE POLYETHER RUBBER IMPRESSION | ELW | Substantially Equivalent | Espe Dental Products | accessdata.fda.gov |
| August 31, 1978 | K781151 | REPROSIL | ELW | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| May 12, 1978 | K780745 | RUBBER DAM | EIE | Substantially Equivalent | Hygienic Dental Mfg., Co., The | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Impression
- All makers of Agent, Tooth Bonding, Resin
- All makers of Agent, Polishing, Abrasive, Oral Cavity
- All makers of Handpiece, Air-Powered, Dental
- All makers of Material, Tooth Shade, Resin
- All makers of Crown And Bridge, Temporary, Resin
Updated September 11, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.