Registered with FDA
Soher Med Limited
Hong Kong, Hong Kong SAR China. Lists 67 dental device types with FDA across 1 registered establishment.
- Device types listed
- 67
- Brands and models
- 131
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Hong Kong SAR China
Devices listed with FDA
What Soher Med Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | coreDentalDental Cementdental compositeDental FillingDental Filling MaterialFlowPit & Fissureshade resinshare resin 4 moretooth bondingTooth resinTooth shadeZ350 | 2026 |
| Dental CementEMA · Class 2 | Dental cements | Lister | Dental CementFuji LiningMaxcemNX3Tooth shade | 2026 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | BondBondingdental bonddental bondingdental cementOptiBondshadetooth bondtooth bondingtooth shade | 2026 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | dentalDental CementDental ImpressionExpressImpressionImpression DentalImpression materialMATERIAL, IMPRESSIONOcclufastshare resin | 2026 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | C&BCrown & BridgeDental CementdentureLuxatempProtempshadeshade resinStructurtemp C&B 1 moreTemp Crown | 2026 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Lister | dental fillingFlowPit & FissureSealantTooth shade | 2026 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Lister | Coedenturedenture resinKoolinerPerio | 2026 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Lister | dental bonddental bondingFlowTooth bondvarnish | 2026 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Lister | Calcimoldental cementLinerTooth shade | 2026 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Lister | AdhesiveAdhesive, BracketUnitek | 2026 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Lister | Porcelain | 2026 |
| Resin Filling Material CoatingEBD · Class 2 | — | Lister | Filling materialPit & Fissure | 2026 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Lister | AH Plusdental cementdental resin | 2026 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | Dental instrument | 2026 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Lister | LED accessory | 2026 |
| Amalgam AlloyEJJ · Class 2 | — | Lister | Amalgam | 2026 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Lister | dental | 2026 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Lister | Air polishscaler | 2026 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Lister | Denture resin | 2026 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Lister | dental | 2026 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Lister | Dental Needle | 2026 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Lister | Endo | 2026 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | Mirror | 2026 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Lister | Dental Accessory | 2026 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Lister | Tips | 2026 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Lister | Clamp | 2026 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Lister | dental lubricant | 2026 |
| Articulation PaperEFH · Class 1 | — | Lister | Paper, Articulation | 2026 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | Toothbrush | 2026 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | Dental Wax | 2026 |
| X-Ray Film HolderEGZ · Class 1 | — | Lister | Film Holder | 2026 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Lister | — | 2026 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Lister | Cup | 2026 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Lister | abrasive | 2026 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Lister | Polishing | 2026 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | Tray | 2026 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Lister | irrigating | 2026 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | Composite dispensing | 2026 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | Mixing Tips | 2026 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Lister | Instrument | 2026 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Lister | Dental instrument | 2026 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | bur dental | 2026 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Lister | Explorer | 2026 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Lister | Burnisher | 2026 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Lister | endo spreader | 2026 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Lister | Gutta percha | 2026 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Lister | paper point | 2026 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Lister | dental instrument | 2026 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Lister | Endo file | 2026 |
| Endodontic CuretteEKT · Class 1 | Dental hand instruments | Lister | Curette | 2026 |
| Porcelain TeethELL · Class 2 | Dental ceramics & zirconia | Lister | tooth bond | 2026 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Lister | Denture | 2026 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Lister | Posts | 2026 |
| Preformed CrownELZ · Class 1 | — | Lister | Crowns | 2026 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Lister | Forecep | 2026 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Lister | Dental elevator | 2026 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Lister | — | 2026 |
| Periodontic FileEMR · Class 1 | Dental hand instruments | Lister | File | 2026 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Lister | retainer | 2026 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Lister | Plier | 2026 |
| Paper Saliva AbsorberKHR · Class 1 | — | Lister | absorber | 2026 |
| Resin ApplicatorKXR · Class 1 | — | Lister | Applicatory Resin | 2026 |
| Dental Stain EraserMAU · Class 1 | — | Lister | Dental Cement | 2026 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Lister | xray accessory | 2026 |
| Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering for Pain ReliefMZW · Class 2 | — | Lister | Maxcem | 2026 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Lister | accessories | 2026 |
| External Cleaning SolutionPME · Class 2 | — | Lister | varnish | 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
Soher Med Limited 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. (48), Ivoclar Vivadent, AG (17), Voco GmbH (10), Sybron Dental Specialties (10), Heraeus Kulzer, LLC (10), 3M Company (10), Dentsply Intl., Inc. (10), Shofu Inc (9).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 22 Nov 2019 | K192260 | everX Flow | GC America Inc. | EBF Resin Tooth Shade Material |
| 8 Oct 2019 | K191133 | KATANA Cleaner, KATANA Cleaner (Trial) | Kuraray Noritake Dental, Inc. | PME External Cleaning Solution |
| 29 Jul 2019 | K190339 | Helioseal F Plus | Ivoclar Vivadent, AG | EBC Pit and Fissure Sealant and Conditioner |
| 14 Mar 2019 | K183380 | Tetric PowerFill | Ivoclar Vivadent, AG | EBF Resin Tooth Shade Material |
| 18 Dec 2018 | K181496 | VINTAGE PRO | Shofu Inc | EIH Porcelain Powder |
| 8 Mar 2018 | K173500 | NMF004A | GC America Inc. | EBF Resin Tooth Shade Material |
| 27 Feb 2018 | K173275 | OMNICHROMA | Tokuyama Dental Corporation | EBF Resin Tooth Shade Material |
| 4 Apr 2017 | K163613 | Bluephase Style 20i | Ivoclar Vivadent, AG | EBZ Ultraviolet Activator for Polymerization |
| 27 Sep 2016 | K162107 | TPH Spectra+ Universal Composite Restorative | Dentsply Sirona, Inc. | EBF Resin Tooth Shade Material |
| 29 Jul 2016 | K153493 | Clip Flow | Voco GmbH | 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 |
| 27 Jul 2016 | K160596 | BEAUTIFIL II LS | Shofu Inc | EBF Resin Tooth Shade Material |
| 12 Jul 2016 | K153325 | Gradia Plus | GC America Inc. | EBF Resin Tooth Shade Material |
| 6 Jul 2016 | K153231 | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer | GC America Inc. | EMA Dental Cement |
| 30 Jun 2016 | K153177 | Admira Fusion Flow | Voco GmbH | EBF Resin Tooth Shade Material |
| 14 Apr 2016 | K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes | Sybron Dental Specialties | KIF Root Canal Filling Resin |
| 12 Apr 2016 | K153753 | TelioCAD Multi | Ivoclar Vivadent, AG | EBG Resin Temporary Crown and Bridge |
| 4 Mar 2016 | K152861 | Aquasil Ultra + Smart Wetting Impression Material | Dentply International, Inc. | ELW Impression Material |
| 3 Mar 2016 | K153253 | GC Reline II | GC America Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 2 Mar 2016 | K151700 | BEAUTIFIL II Gingiva | Shofu Inc | EBF Resin Tooth Shade Material |
| 10 Dec 2015 | K151699 | BEAUTIFIL II Enamel | Shofu Inc | EBF Resin Tooth Shade Material |
| 31 Jul 2015 | K151053 | PSPIX 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 scanner | Sopro - Acteon Group | MUH Digital Extraoral Source X-Ray System |
| 7 Jul 2015 | K150933 | iBond Universal & iBond Ceramic Primer | Heraeus Kulzer, LLC (Mitsui Chemicals Group) | KLE Resin Tooth Bonding Agent |
| 20 Apr 2015 | K143140 | G-Premio BOND | GC America Inc. | KLE Resin Tooth Bonding Agent |
| 25 Nov 2014 | K142389 | Variolink Esthetic | Ivoclar Vivadent, AG | EBF Resin Tooth Shade Material |
| 5 Sep 2014 | K141562 | MSN-006 | GC America Inc. | EBG Resin Temporary Crown and Bridge |
| 14 Mar 2014 | K133824 | CERASMART | GC America Inc. | EBF Resin Tooth Shade Material |
| 6 Mar 2014 | K133836 | OPTIGLAZE COLOR | GC America Inc. | EBD Resin Filling Material Coating |
| 11 Feb 2014 | K133318 | ADHESE UNIVERSAL | Ivoclar Vivadent, AG | KLE Resin Tooth Bonding Agent |
| 1 Nov 2013 | K132450 | CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND | Kuraray Noritake Dental, Inc. | KLE Resin Tooth Bonding Agent |
| 3 Oct 2013 | K132141 | BEAUTIFIL BULK FLOWABLE | Shofu Inc | EBF Resin Tooth Shade Material |
| 11 Jul 2013 | K131248 | ETCH GEL | DMG America, L.L.C. | KLE Resin Tooth Bonding Agent |
| 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 |
| 29 Aug 2012 | K121230 | IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE | Ivoclar Vivadent, AG | EBF Resin Tooth Shade Material |
| 10 May 2012 | K120521 | GC BLUE SILICONE | GC America Inc. | ELW Impression Material |
| 19 Mar 2012 | K120453 | FILTEK BULK FILL FLOWABLE RESTORATIVE | 3M Espe Dental Products | EBF Resin Tooth Shade Material |
| 14 Dec 2011 | K112501 | VENUS PEARL PLT REFILL A1 | Heraeus Kulzer, LLC | EBF Resin Tooth Shade Material |
| 17 Nov 2011 | K111982 | CLEARFIL DC CORE PLUS | Kuraray America, Inc. | EBF Resin Tooth Shade Material |
| 14 Oct 2011 | K111958 | TETRIC EVOCERAM BULK FILL | Ivoclar Vivadent, AG | EBF Resin Tooth Shade Material |
| 17 Jun 2011 | K110871 | FIT CHECKER ADVANCED | GC America Inc. | ELW Impression Material |
| 19 May 2011 | K110302 | ADHESIVE EXL-759 | 3M Espe AG | KLE Resin Tooth Bonding Agent |
| 5 May 2011 | K111185 | RELYX LUTING PLUS AUTOMIX | 3M Espe Dental Products | EMA Dental Cement |
| 25 Feb 2011 | K103528 | IPS EMPRESS DIRECT FLOW | Ivoclar Vivadent, AG | EBF Resin Tooth Shade Material |
| 14 Feb 2011 | K103379 | TELIO CS INLAY & TELIO CS ONLAY | Ivoclar Vivadent, AG | EBG Resin Temporary Crown and Bridge |
| 22 Dec 2010 | K102808 | MI VARNISH | GC America Inc. | LBH Cavity Varnish |
| 21 Oct 2010 | K100172 | TOKUYAMA SHIELD FORCE | Tokuyama Dental Corporation | LBH Cavity Varnish |
| 28 Sep 2010 | K101710 | LUXATEMP ULTRA /STAR | Dmg USA, Inc. | EBG Resin Temporary Crown and Bridge |
| 17 Sep 2010 | K101420 | GC FUJI TEMP | GC America Inc. | EMA Dental Cement |
| 23 Aug 2010 | K101603 | BEAUTIFIL FLOW PLUS | Shofu Inc | EBF Resin Tooth Shade Material |
| 19 Aug 2010 | K101493 | ADVANCED GLASS IONOMER (K-130) RESTORATIVE | Dentsply International, Inc. | EMA Dental Cement |
| 12 May 2010 | K100235 | FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE | 3M Company | EBF Resin Tooth Shade Material |
| 10 Mar 2010 | K092141 | VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH | 3M Espe Dental Products | LBH Cavity Varnish |
| 10 Mar 2010 | K093744 | EXCITE F AND EXCITE DSC | Ivoclar Vivadent, AG | KLE Resin Tooth Bonding Agent |
| 5 Mar 2010 | K100328 | CLEARFIL MAJETY POSTERIOR | Kuraray Medical, Inc. | EBF Resin Tooth Shade Material |
| 31 Jul 2009 | K091494 | FLEXITIME FLOW | Heraeus Kulzer, LLC | ELW Impression Material |
| 22 Jul 2009 | K091388 | GCUC-505 | GC America Inc. | EBF Resin Tooth Shade Material |
| 17 Jun 2009 | K091106 | EQUIA | GC America Inc. | EMA Dental Cement |
| 4 Jun 2009 | K091019 | SPEEDCEM | Ivoclar Vivadent, AG | EMA Dental Cement |
| 21 May 2009 | K091023 | METAMORPHOSIS | Sybron Dental Specialties | EBF Resin Tooth Shade Material |
| 11 May 2009 | K090826 | MONOBOND PLUS | Ivoclar Vivadent, AG | KLE Resin Tooth Bonding Agent |
| 29 Apr 2009 | K090701 | EMPRESS DIRECT | Ivoclar Vivadent, AG | EBF Resin Tooth Shade Material |
| 21 Jan 2009 | K083652 | IBOND TOTAL ETCH | Heraeus Kulzer, 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 | K082744 | BEAUTIBOND | Shofu Inc | KLE Resin Tooth Bonding Agent |
| 30 Oct 2008 | K082171 | GRADIA CORE | GC America Inc. | EBF Resin Tooth Shade Material |
| 21 Oct 2008 | K082768 | G-BOND PLUS | GC America Inc. | KLE Resin Tooth Bonding Agent |
| 19 Jun 2008 | K080940 | ESTELITE SIGMA QUICK | Tokuyama Dental Corporation | EBF Resin Tooth Shade Material |
| 15 Feb 2008 | K073697 | TRANSBOND SUPREME ADHESIVE | 3M Unitek Corporation | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 4 Feb 2008 | K073554 | NEUN | Heraeus Kulzer, LLC | EBF Resin Tooth Shade Material |
| 29 Jan 2008 | K073209 | MAXCEM 2 | Sybron Dental Specialties | MZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering for Pain Relief |
| 15 Aug 2007 | K071742 | BEAUTIFIL II | Shofu Inc | EBF Resin Tooth Shade Material |
| 19 Jul 2007 | K071288 | MODIFICATION TO KAVO QUATTROCARE | Sybron Dental Specialties | EBF Resin Tooth Shade Material |
| 7 Jun 2007 | K070723 | FUTURABOND DC/SINGLE DOSE | Voco GmbH | KLE Resin Tooth Bonding Agent |
| 12 Apr 2007 | K070854 | GC MI PASTE PLUS | GC America Inc. | EJR Oral Cavity Abrasive Polishing Agent |
| 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 |
| 21 Mar 2007 | K070325 | CLEARFIL MAJESTY ESTHETIC PLT | Kuraray Medical, Inc. | EBF Resin Tooth Shade Material |
| 14 Jul 2006 | K061535 | GC XLC-100 CAPSULE | GC America Inc. | EMA Dental Cement |
| 24 Apr 2006 | K060684 | ADPER PROMPT, ADPER PROMPT L-POP | 3M Espe AG Dental Products | KLE Resin Tooth Bonding Agent |
| 3 Feb 2006 | K053565 | TEMPBOND CLEAR WITH TRICLOSAN | Sybron Dental Specialties | EMA Dental Cement |
| 20 Oct 2005 | K052462 | G-COAT | GC America Inc. | EBD Resin Filling Material Coating |
| 14 Oct 2005 | K051705 | IPS E.MAX CAD/IPS E.MAX ZIRCAD | Ivoclar Vivadent, AG | EIH Porcelain Powder |
| 8 Aug 2005 | K051808 | ESTELITE FLOW QUICK | Tokuyama Dental Corporation | EBF Resin Tooth Shade Material |
| 27 Jul 2005 | K051867 | GRANDIO | Voco GmbH | EBF Resin Tooth Shade Material |
| 15 Jul 2005 | K051424 | HYDROGUM 5 | Dentsply Sirona, Inc. | ELW Impression Material |
| 28 Jun 2005 | K051535 | MODIFICATION TO:REGISTRADO X-TRA | Voco GmbH | ELW Impression Material |
| 22 Apr 2005 | K050880 | DYRACT EXTRA RESTORATIVE | Dentsply Intl., Inc. | EBF Resin Tooth Shade Material |
| 18 Nov 2004 | K042348 | GRADIA DIRECT LOFLO | GC America Inc. | EBF Resin Tooth Shade Material |
| 9 Nov 2004 | K042819 | TETRIC EVOCERAM | Ivoclar Vivadent, AG | EBF Resin Tooth Shade Material |
| 29 Jun 2004 | K041471 | G-BOND | GC America Inc. | KLE Resin Tooth Bonding Agent |
| 16 Jun 2004 | K040906 | CALIBRA CEMENT | Dentsply Intl., Inc. | EMA Dental Cement |
| 30 Apr 2004 | K040393 | RIVA LUTING | Southern Dental Industries, Inc. | EMA Dental Cement |
| 22 Apr 2004 | K040567 | GC INITIAL MC, AL AND LF | GC America Inc. | EIH Porcelain Powder |
| 7 Apr 2004 | K040769 | STRUCTUR 2 SC | Voco GmbH | EBG Resin Temporary Crown and Bridge |
| 30 Dec 2003 | K033665 | VENUS FLOW | Heraeus Kulzer, LLC | EBF Resin Tooth Shade Material |
| 5 Dec 2003 | K033520 | BLUEPHASE | Ivoclar Vivadent, AG | EBZ Ultraviolet Activator for Polymerization |
| 21 Nov 2003 | K033022 | PROTEMP 3 GARANT | 3M Espe AG Dental Products | EBG Resin Temporary Crown and Bridge |
| 7 Nov 2003 | K032455 | PANAVIA F 2.0 | Kuraray Medical, Inc. | EMA Dental Cement |
| 2 Jul 2003 | K031444 | OPTIBOND FL | Kerr Dental Materials Center | KLE Resin Tooth Bonding Agent |
| 10 Apr 2003 | K030072 | EVERSTICK PERIO | GC America Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 30 Jan 2003 | K023814 | GRADIA DIRECT | GC America Inc. | EBF Resin Tooth Shade Material |
| 18 Dec 2002 | K024034 | OCCLUFAST ROCK | Dentsply Sirona, Inc. | ELW Impression Material |
| 2 Oct 2002 | K022641 | TOKUYAMA REBASE II | Tokuyama America, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 13 May 2002 | K021126 | EVERSTICK ORTHO | GC America Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 10 May 2002 | K021413 | AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL | Dentsply Intl., Inc. | ELW Impression Material |
| 26 Apr 2002 | K020578 | GC FUJI ORTHO BAND PASTE PAK | GC America Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 12 Apr 2002 | K020287 | DENTITION INTEGRATING MATERIAL | Pulpdent Corporation | EBC Pit and Fissure Sealant and Conditioner |
| 28 Feb 2002 | K020117 | GC FUJI LINING LC PASTE PAK | GC America Inc. | EMA Dental Cement |
| 24 Jan 2002 | K013674 | LUXATEMP/LUXATEMP SOLAR/INSTATEMP | Dmg USA, Inc. | EBG Resin Temporary Crown and Bridge |
| 16 Jan 2002 | K013609 | NEXUS 2 CLEAR | Sybron Dental Specialties | EMA Dental Cement |
| 29 Oct 2001 | K013198 | FUJI VII CAPSULE | GC America Inc. | EMA Dental Cement |
| 22 Oct 2001 | K012528 | ICE | Southern Dental Industries, Inc. | EBF Resin Tooth Shade Material |
| 16 Oct 2001 | K012542 | REVOTEK LC | GC America Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 10 Sep 2001 | K012442 | MODIFICATION TO CLEARFIL SE BOND | Kuraray Medical, Inc. | KLE Resin Tooth Bonding Agent |
| 5 Sep 2001 | K012440 | MODIFICATION TO CLEARFIL LINER BOND 2V | Kuraray Medical, Inc. | KLE Resin Tooth Bonding Agent |
| 5 Sep 2001 | K012438 | MODIFICATION TO PANAVIA 21 | Kuraray Medical, Inc. | EMA Dental Cement |
| 4 Sep 2001 | K012432 | MODIFICATION TO CLEARFIL PHOTO BOND | Kuraray Medical, Inc. | KLE Resin Tooth Bonding Agent |
| 18 Jun 2001 | K011211 | FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW | Dmg USA, Inc. | EBF Resin Tooth Shade Material |
| 15 Feb 2001 | K003650 | PERMLASTIC 3 | Sybron Dental Specialties | ELW Impression Material |
| 16 Jan 2001 | K003817 | PATTERN RESIN | GC America Inc. | EBG Resin Temporary Crown and Bridge |
Showing the 120 most recent of 199.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SOHER MED LIMITEDFDA reg. 3045857207 | Hong Kong, Hong Kong SAR China | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10095823). 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.