Registered with FDA
Oketz Logistics LLC
Coral Gables, FL, United States. Lists 121 dental device types with FDA across 1 registered establishment.
- Device types listed
- 121
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Oketz Logistics LLC currently lists, by FDA device type, with the brand and model names on the listing.
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
Oketz Logistics LLC 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. (45), Sybron Dental Specialties (21), Bisco, Inc. (18), Pulpdent Corporation (15), Ivoclar Vivadent, AG (14), Heraeus Kulzer, LLC (13), Kuraray Medical, Inc. (13), Dentsply Intl., Inc. (13).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 13 Jan 2022 | K203706 | Dental Electric Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | EBW Handpiece and Cord Foot Controller |
| 13 Oct 2021 | K211905 | UltraCal XS | Ultradent Products, Inc. | KIF Root Canal Filling Resin |
| 7 Oct 2021 | K212279 | Digital Intraoral X-ray Imaging System | Iray Technology Taicang , Ltd. | MUH Digital Extraoral Source X-Ray System |
| 27 Sep 2021 | K212080 | Imaging Plate Scanner, i-Scan | Guilin Woodpecker Medical Instrument Co., Ltd. | MUH Digital Extraoral Source X-Ray System |
| 10 May 2021 | K203320 | Endo Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
| 24 Sep 2020 | K201684 | A-Silicone for Bite Registration | Shandong Huge Dental Material Corporation | ELW Impression Material |
| 1 Apr 2020 | K200188 | DSI Dental Implant System | DSI Dental Solutions Ltd | DZE Root-Form Endosseous Implant |
| 22 Nov 2019 | K192260 | everX Flow | GC America Inc. | EBF Resin Tooth Shade Material |
| 22 Nov 2019 | K191103 | Parkell Desensitizer Gel | Parkell, Inc | EJK Calcium Hydroxide Cavity Liner |
| 20 Nov 2019 | K191865 | SmartLite Pro Modular LED Curing Light | Dentsply Sirona, Inc. | EBZ Ultraviolet Activator for Polymerization |
| 8 Oct 2019 | K191133 | KATANA Cleaner, KATANA Cleaner (Trial) | Kuraray Noritake Dental, Inc. | PME External Cleaning Solution |
| 27 Feb 2018 | K173275 | OMNICHROMA | Tokuyama Dental Corporation | EBF Resin Tooth Shade Material |
| 13 Feb 2018 | K172839 | ENDOSOLV | Septodont | KIF Root Canal Filling Resin |
| 31 Jul 2017 | K170207 | Obturys | ITENA Clinical | KIF Root Canal Filling Resin |
| 26 Jul 2017 | K170812 | HygePLUS Alginate Impression Material | Hygedent, Inc. | ELW Impression Material |
| 18 Jul 2017 | K162856 | Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) | Bonart Co., Ltd. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 21 Feb 2017 | K163317 | ELECTROmatic | Kaltenbach & Voigt Gmgh | EBW Handpiece and Cord Foot Controller |
| 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 |
| 13 Jul 2016 | K160551 | VALO Grand | Ultradent Products, Inc. | EBZ Ultraviolet Activator for Polymerization |
| 20 May 2016 | K153334 | Oral-B 5% Sodium Fluoride Varnish | Young Innovations Inc | LBH Cavity Varnish |
| 14 Apr 2016 | K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes | Sybron Dental Specialties | KIF Root Canal Filling Resin |
| 3 Mar 2016 | K153253 | GC Reline II | GC America Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 10 Sep 2015 | K151526 | Zone, ZoneFree, Zone A1 | Sybron Dental Specialties | EMA Dental Cement |
| 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 |
| 28 Jul 2015 | K151150 | Elements | Pac-Dent International, Inc. | ELW Impression Material |
| 7 Jul 2015 | K150933 | iBond Universal & iBond Ceramic Primer | Heraeus Kulzer, LLC (Mitsui Chemicals Group) | KLE Resin Tooth Bonding Agent |
| 17 Jun 2015 | K150727 | ESTECEM | Tokuyama Dental Corporation | EMA Dental Cement |
| 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 |
| 28 May 2014 | K133071 | ELASTIC IMPRESSION MATERIAL | Rizhao Huge Dental Industry Co., Ltd. | ELW Impression Material |
| 14 Mar 2014 | K133824 | CERASMART | GC America Inc. | EBF Resin Tooth Shade Material |
| 11 Feb 2014 | K133318 | ADHESE UNIVERSAL | Ivoclar Vivadent, AG | KLE Resin Tooth Bonding Agent |
| 26 Nov 2013 | K131997 | NEWTRON BOOSTER | Satelec - Acteon Group | ELC Ultrasonic Scaler |
| 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 |
| 6 Sep 2013 | K131442 | FIRECR DENTALIMAGING SYSTEM | 3DISC Americas | MUH Digital Extraoral Source X-Ray System |
| 13 Aug 2013 | K130672 | OPTIFLOW II FLOWABLE COMPOSITE, LC | Pac-Dent International, Inc. | EBF Resin Tooth Shade Material |
| 11 Jul 2013 | K131248 | ETCH GEL | DMG America, L.L.C. | KLE Resin Tooth Bonding Agent |
| 19 Apr 2013 | K121804 | PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM | ITENA Clinical | EMA Dental Cement |
| 29 Mar 2013 | K130223 | RMGI FILL | Pulpdent Corporation | EMA Dental Cement |
| 19 Mar 2013 | K122522 | DENTOETCH QUICKBOND BOND ACTIVATOR | ITENA Clinical | KLE Resin Tooth Bonding Agent |
| 5 Mar 2013 | K121769 | DENTOCORE / DENTOCORE BODY | ITENA Clinical | EBF Resin Tooth Shade Material |
| 31 Jan 2013 | K123397 | MULTILINK AUTOMIX | Ivoclar Vivadent, AG | 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 |
| 7 Dec 2012 | K123273 | HOFFMANN'S CEMENT (PHOSPHATE, NORMAL) | Temrex Corp. | EMA Dental Cement |
| 23 Aug 2012 | K121824 | ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 | Lascod Spa | ELW Impression Material |
| 6 Aug 2012 | K121698 | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN | Dentsply International, Inc. | EJR Oral Cavity Abrasive Polishing Agent |
| 27 Jun 2012 | K120243 | GAM-200 | GC America Inc. | EMA Dental Cement |
| 8 Jun 2012 | K120784 | TUFF-TEMP 2.0 | Pulpdent Corporation | EBG Resin Temporary Crown and Bridge |
| 10 May 2012 | K120521 | GC BLUE SILICONE | GC America Inc. | ELW Impression Material |
| 30 Mar 2012 | K120379 | PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S | Kuraray Medical, Inc. | EMA Dental Cement |
| 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 |
| 9 Dec 2011 | K112946 | ACTIV VARNISH | Pulpdent Corporation | LBH Cavity Varnish |
| 29 Nov 2011 | K111087 | FOUNDATION | Olympus Terumo Biomaterials Corporation | LYC Synthetic Bone Grafting Material |
| 18 Nov 2011 | K111290 | PIEZO BONE SURGERY | Guilin Woodpecker Medical Instrument Co., Ltd. | DZI Powered Bone Drill |
| 17 Nov 2011 | K111982 | CLEARFIL DC CORE PLUS | Kuraray America, Inc. | EBF Resin Tooth Shade Material |
| 28 Oct 2011 | K112445 | SOFRELINER TOUGH S | Tokuyama Dental Corporation | EBI Rebasing Repairing Relining Denture Resin |
| 14 Oct 2011 | K111958 | TETRIC EVOCERAM BULK FILL | Ivoclar Vivadent, AG | EBF Resin Tooth Shade Material |
| 23 Sep 2011 | K112517 | ULTRASEAL XT HYDRO | Ultradent Products, Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 17 Jun 2011 | K102917 | FIXTEMP C&B | Exacta Dental Direct, Inc. | EBG Resin Temporary Crown and Bridge |
| 17 Jun 2011 | K110871 | FIT CHECKER ADVANCED | GC America Inc. | ELW Impression Material |
| 27 May 2011 | K110642 | SILJETR SYSTEM | Danville Materials, LLC | EBF Resin Tooth Shade Material |
| 5 May 2011 | K111185 | RELYX LUTING PLUS AUTOMIX | 3M Espe Dental Products | EMA Dental Cement |
| 5 Apr 2011 | K110378 | IMPRESSION COMPOUND | Sybron Dental Specialties | ELW Impression Material |
| 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 |
| 4 Feb 2011 | K102753 | TURBO TEMP 3 | Danville Materials, LLC | EBG Resin Temporary Crown and Bridge |
| 2 Feb 2011 | K103190 | PROFIL COMPOSITES (PROFIL, PROFIL FLOW) | Silmet , Ltd. | EBF Resin Tooth Shade Material |
| 20 Jan 2011 | K103351 | DMC COMPOSITE 2 | Sybron Dental Specialties | EBF Resin Tooth Shade Material |
| 22 Dec 2010 | K102808 | MI VARNISH | GC America Inc. | LBH Cavity Varnish |
| 8 Dec 2010 | K102984 | AURA | Sdi Limited | EBF Resin Tooth Shade Material |
| 10 Nov 2010 | K103164 | VONFLEX HEAVY, VINFLEX LIGHT | Vericom Co., Ltd. | ELW Impression Material |
| 26 Oct 2010 | K103121 | ECO-S | Vericom Co., Ltd. | EBC Pit and Fissure Sealant and Conditioner |
| 21 Oct 2010 | K100172 | TOKUYAMA SHIELD FORCE | Tokuyama Dental Corporation | LBH Cavity Varnish |
| 8 Oct 2010 | K101787 | DUOLINK II | Bisco, Inc. | EMA Dental Cement |
| 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 |
| 11 Aug 2010 | K102128 | VITABLOCS | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | EIH Porcelain Powder |
| 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 |
| 5 Mar 2010 | K093575 | GLUMA DESENSITIZER POWER GEL | Heraeus Kulzer, LLC | LBH Cavity Varnish |
| 17 Feb 2010 | K093470 | CORE-FLO D/C | Bisco, Inc. | EBF Resin Tooth Shade Material |
| 30 Oct 2009 | K091512 | BUILD-IT LIGHT CURE | Pentron Clinical Technologies | EBF Resin Tooth Shade Material |
| 28 Aug 2009 | K091705 | PRIMER PLUS | Bisco, Inc. | KLE Resin Tooth Bonding Agent |
| 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 Jul 2009 | K090941 | ADHESE ONE F | Ivoclar Vivadent, AG | KLE Resin Tooth Bonding Agent |
| 17 Jun 2009 | K091106 | EQUIA | GC America Inc. | EMA Dental Cement |
| 5 Jun 2009 | K083195 | MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN | Lang Dental Mfg. Co., Inc. | EBG Resin Temporary Crown and Bridge |
| 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 |
| 23 Mar 2009 | K090083 | CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 | Unicare Biomedical, Inc. | LYC Synthetic Bone Grafting Material |
| 21 Jan 2009 | K083652 | IBOND TOTAL ETCH | Heraeus Kulzer, LLC | KLE Resin Tooth Bonding Agent |
| 11 Dec 2008 | K082744 | BEAUTIBOND | Shofu Inc | KLE Resin Tooth Bonding Agent |
| 17 Nov 2008 | K081981 | LANG DENTAL ACRYLIC PRIMER | Lang Dental Mfg. Co., Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 21 Oct 2008 | K082768 | G-BOND PLUS | GC America Inc. | KLE Resin Tooth Bonding Agent |
| 25 Sep 2008 | K082449 | BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 | Bisco, Inc. | EMA Dental Cement |
| 22 Sep 2008 | K081514 | TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER | Lang Dental Mfg. Co., Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 4 Aug 2008 | K081017 | TEMPLATE AND COUNTER-FIT | Clinician'S Choice Dental Products, Inc. | ELW Impression Material |
| 24 Jul 2008 | K080814 | VOCO PROFLUORID VARNISH | Voco GmbH | LBH Cavity Varnish |
| 19 Mar 2008 | K080025 | LED.L, LED.M, LED.G, LED.B | Guilin Woodpecker Medical Instrument Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 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 |
| 23 Jan 2008 | K073173 | SELF-ADHESIVE RESIN CEMENT | Dentsply Interntional | EMA Dental Cement |
| 21 Nov 2007 | K072480 | GENERATION 8 SE ADHESIVE | Pentron Clinical Technologies | KLE Resin Tooth Bonding Agent |
| 16 Nov 2007 | K072604 | DUO TEMP | Coltene/Whaledent AG | EMA Dental Cement |
| 14 Nov 2007 | K072554 | ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES | Sable Industries, Inc. | EFB Dental Air-Powered Handpiece |
| 5 Nov 2007 | K072580 | JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23 | Lang Dental Mfg. Co., Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 18 Oct 2007 | K071632 | PERFECT TISSUE CONTOURING SYSTEM II | Coltene/Whaledent AG | EKZ Dental Electrosurgical Unit and Accessories |
| 15 Aug 2007 | K071742 | BEAUTIFIL II | Shofu Inc | EBF Resin Tooth Shade Material |
| 26 Jul 2007 | K071251 | DEMI | Sybron Dental Specialties | EBZ Ultraviolet Activator for Polymerization |
Showing the 120 most recent of 412.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| OKETZ LOGISTICS LLCFDA reg. 3038718579 | Coral Gables, FL, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10093578). 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.