Data / Medical devices / United States / Oketz Logistics LLC
Oketz Logistics LLC: FDA-registered device maker in Coral Gables, FL, United States, 486 510(k) clearances
Oketz Logistics LLC is registered with the FDA (registration 3038718579) in Coral Gables, FL, United States. It lists 202 device types. The FDA files 486 510(k) clearances under its listings, the newest dated January 31, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3038718579
- Address
- 50 Minorca Ave, Coral Gables, FL, United States, 33134
- Owner or operator
- Oketz Logistics LLC (10093578)
- Roles
- Repackager or relabeler
- First device listed
- June 17, 2008
- Registered through
- 2027
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. Newest 100 of 486.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 31, 2025 | K243441 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) | LZA | Substantially Equivalent | Basic Medical Technology, Inc. | accessdata.fda.gov |
| January 16, 2024 | K231144 | Washtrays | KCT | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| August 22, 2023 | K231510 | Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) | FYA | Substantially Equivalent | Xiantao Zhibo Non-Woven Products Co., Ltd. | accessdata.fda.gov |
| February 13, 2023 | K221875 | Sterilization Pouch and Roll | FRG | Substantially Equivalent | Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. | accessdata.fda.gov |
| November 10, 2022 | K222551 | Humask Pro Vision, Humask Pro Vision 3000 | FXX | Substantially Equivalent | Entreprise Premont, Inc. | accessdata.fda.gov |
| April 25, 2022 | K220512 | Disposable Surgical Face Mask (M01, M02) | FXX | Substantially Equivalent | Fomed Industries, Inc. | accessdata.fda.gov |
| January 13, 2022 | K203706 | Dental Electric Motor | EBW | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| October 13, 2021 | K211905 | UltraCal XS | KIF | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| October 7, 2021 | K212279 | Digital Intraoral X-ray Imaging System | MUH | Substantially Equivalent | Iray Technology Taicang , Ltd. | accessdata.fda.gov |
| September 27, 2021 | K212080 | Imaging Plate Scanner, i-Scan | MUH | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| June 2, 2021 | K210150 | Disposable Medical mask | FXX | Substantially Equivalent | Hubei Wanli Protective Products Co., Ltd. | accessdata.fda.gov |
| May 10, 2021 | K203320 | Endo Motor | EKX | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| March 30, 2021 | K202708 | Surgical Face Masks | FXX | Substantially Equivalent | Intco Medical(Hk) Co., Ltd. | accessdata.fda.gov |
| March 19, 2021 | K203593 | Patient Examination Gloves | LZA | Substantially Equivalent | Guangdong Kingfa Sci. & Tech.Co., Ltd. | accessdata.fda.gov |
| November 20, 2020 | K193346 | Codman Surgical Patties & Strips | HBA | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| September 24, 2020 | K201684 | A-Silicone for Bite Registration | ELW | Substantially Equivalent | Shandong Huge Dental Material Corporation | accessdata.fda.gov |
| July 2, 2020 | K200766 | 3M Attest Steam Chemical Integrator Test Pack | FRC | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| April 1, 2020 | K200188 | DSI Dental Implant System | DZE | Substantially Equivalent | Dsi Dental Solutions, Ltd. | accessdata.fda.gov |
| December 31, 2019 | K192444 | mCare® Powder Free Nitrile Black Examination Glove | LZA | Substantially Equivalent | Mercator Medical (Thailand), Ltd. | accessdata.fda.gov |
| November 22, 2019 | K192260 | everX Flow | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| November 22, 2019 | K191103 | Parkell Desensitizer Gel | EJK | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
| November 20, 2019 | K191865 | SmartLite Pro Modular LED Curing Light | EBZ | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| October 8, 2019 | K191448 | Barrier Sleeves | PEM | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| October 8, 2019 | K191133 | KATANA Cleaner, KATANA Cleaner (Trial) | PME | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| July 9, 2019 | K181957 | Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted | FRG | Substantially Equivalent | Tianchang Jiarui Packaging Material Co., Ltd. | accessdata.fda.gov |
| December 18, 2018 | K181087 | Apex Locator, DPEX III | LQY | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| May 3, 2018 | K171577 | Smartcord, Smartcord X | MVL | Substantially Equivalent | Eastdent Co., Ltd. | accessdata.fda.gov |
| April 13, 2018 | K172930 | mCare Powder-free Blue Nitrile Examination Gloves | LZA | Substantially Equivalent | Mercator Medical (Thailand), Ltd. | accessdata.fda.gov |
| February 27, 2018 | K173275 | OMNICHROMA | EBF | Substantially Equivalent | Tokuyama Dental Corporation | accessdata.fda.gov |
| February 13, 2018 | K172839 | ENDOSOLV | KIF | Substantially Equivalent | Septodont | accessdata.fda.gov |
| January 25, 2018 | K173062 | Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) | FXX | Substantially Equivalent | V&Q Manufacturing Corporation | accessdata.fda.gov |
| October 20, 2017 | K162662 | GingiDent Gingival Retraction Paste | MVL | Substantially Equivalent | Pac-Dent International, Inc. | accessdata.fda.gov |
| August 8, 2017 | K162948 | Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials | MVL | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| July 31, 2017 | K170207 | Obturys | KIF | Substantially Equivalent | Itena Clinical | accessdata.fda.gov |
| July 26, 2017 | K170812 | HygePLUS Alginate Impression Material | ELW | Substantially Equivalent | Hygedent, Inc. | accessdata.fda.gov |
| July 18, 2017 | K162856 | Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) | EGS | Substantially Equivalent | Bonart Co., Ltd. | accessdata.fda.gov |
| April 28, 2017 | K162258 | Self Sealing Sterilization Pouches | FRG | Substantially Equivalent | Tianchang Jiarui Packaging Material Co., Ltd. | accessdata.fda.gov |
| February 21, 2017 | K163317 | ELECTROmatic | EBW | Substantially Equivalent | Kaltenbach & Voigt Gmgh | accessdata.fda.gov |
| January 13, 2017 | K162164 | GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord | MVL | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| July 29, 2016 | K153493 | Clip Flow | EBF | Substantially Equivalent | Voco GmbH | 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 |
| July 13, 2016 | K160551 | VALO Grand | EBZ | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| June 7, 2016 | K160232 | Disposable Barrier Sleeves and Covers | PEM | Substantially Equivalent | Dentsply International, Inc. | accessdata.fda.gov |
| May 20, 2016 | K153334 | Oral-B 5% Sodium Fluoride Varnish | LBH | Substantially Equivalent | Young Dental Manufacturing Co. 1, LLC | 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 |
| March 3, 2016 | K153253 | GC Reline II | EBI | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| March 3, 2016 | K151123 | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film | PEM | Substantially Equivalent | Pac-Dent International, Inc. | accessdata.fda.gov |
| December 1, 2015 | K152060 | 3M Attest Rapid Readout Biological Indicator 1295 | FRC | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| October 21, 2015 | K151836 | NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| September 10, 2015 | K151526 | Zone, ZoneFree, Zone A1 | EMA | Substantially Equivalent | Sybron Dental Specialties | accessdata.fda.gov |
| September 9, 2015 | K143637 | U&U Sterilization Pouch and Roll | FRG | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
| July 31, 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 | MUH | Substantially Equivalent | Sopro - Acteon Group | accessdata.fda.gov |
| July 28, 2015 | K151150 | Elements | ELW | Substantially Equivalent | Pac-Dent International, Inc. | accessdata.fda.gov |
| July 7, 2015 | K150933 | iBond Universal & iBond Ceramic Primer | KLE | Substantially Equivalent | Heraeus Kulzer, LLC, Mitsui Chemicals Group | accessdata.fda.gov |
| June 17, 2015 | K150727 | ESTECEM | EMA | Substantially Equivalent | Tokuyama Dental Corporation | accessdata.fda.gov |
| April 20, 2015 | K143140 | G-Premio BOND | KLE | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| November 25, 2014 | K142389 | Variolink Esthetic | EBF | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| September 5, 2014 | K141562 | MSN-006 | EBG | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| July 3, 2014 | K133689 | POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK | LZA | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| June 20, 2014 | K140610 | NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| May 28, 2014 | K133071 | ELASTIC IMPRESSION MATERIAL | ELW | Substantially Equivalent | Rizhao Huge Dental Industry Co., Ltd. | accessdata.fda.gov |
| March 14, 2014 | K133824 | CERASMART | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| February 18, 2014 | K132953 | TIDISHEILD | PEM | Substantially Equivalent | Tidi Products,Llc | accessdata.fda.gov |
| February 11, 2014 | K133318 | ADHESE UNIVERSAL | KLE | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| November 26, 2013 | K131997 | NEWTRON BOOSTER | ELC | Substantially Equivalent | Satelec - Acteon Group | accessdata.fda.gov |
| November 26, 2013 | K122024 | SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR | FRC | Substantially Equivalent | Spsmedical Supply Corp. | accessdata.fda.gov |
| November 1, 2013 | K132450 | CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND | KLE | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| October 3, 2013 | K132141 | BEAUTIFIL BULK FLOWABLE | EBF | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| September 6, 2013 | K131442 | FIRECR DENTALIMAGING SYSTEM | MUH | Substantially Equivalent | 3Disc Americas | accessdata.fda.gov |
| August 13, 2013 | K130672 | OPTIFLOW II FLOWABLE COMPOSITE, LC | EBF | Substantially Equivalent | Pac-Dent International, Inc. | accessdata.fda.gov |
| July 11, 2013 | K131248 | ETCH GEL | KLE | Substantially Equivalent | Dmg America, LLC | accessdata.fda.gov |
| April 19, 2013 | K121804 | PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM | EMA | Substantially Equivalent | Itena Clinical | accessdata.fda.gov |
| March 29, 2013 | K130223 | RMGI FILL | EMA | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| March 19, 2013 | K122522 | DENTOETCH QUICKBOND BOND ACTIVATOR | KLE | Substantially Equivalent | Itena Clinical | accessdata.fda.gov |
| March 5, 2013 | K121769 | DENTOCORE / DENTOCORE BODY | EBF | Substantially Equivalent | Itena Clinical | accessdata.fda.gov |
| February 5, 2013 | K123215 | VISCOSTAT CLEAR | MVL | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| January 31, 2013 | K123397 | MULTILINK AUTOMIX | EBF | Substantially Equivalent | Ivoclar Vivadent, AG | 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 |
| December 7, 2012 | K123273 | HOFFMANN'S CEMENT (PHOSPHATE, NORMAL) | EMA | Substantially Equivalent | Temrex Corp. | accessdata.fda.gov |
| October 16, 2012 | K121992 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR | LZA | Substantially Equivalent | Xinwei (Shandong) Plastic and Rubber Products Co., | accessdata.fda.gov |
| August 23, 2012 | K121824 | ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 | ELW | Substantially Equivalent | Lascod Spa | accessdata.fda.gov |
| August 6, 2012 | K121698 | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN | EJR | Substantially Equivalent | Dentsply International, Inc. | accessdata.fda.gov |
| August 3, 2012 | K121526 | POWER-FREE NITRILE PATIENT EXAMINATION GLOVES | LZA | Substantially Equivalent | Shandong Junchi Medical Products Co., Ltd. | accessdata.fda.gov |
| June 27, 2012 | K120243 | GAM-200 | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| June 8, 2012 | K120784 | TUFF-TEMP 2.0 | EBG | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| May 23, 2012 | K112800 | SUNTOUCH TOPICAL HEMOSTATIC DRESSING | QSY | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| May 10, 2012 | K120521 | GC BLUE SILICONE | ELW | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| March 30, 2012 | K120379 | PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S | EMA | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| March 19, 2012 | K120453 | FILTEK BULK FILL FLOWABLE RESTORATIVE | EBF | Substantially Equivalent | 3M Espe Dental Products | accessdata.fda.gov |
| December 14, 2011 | K112501 | VENUS PEARL PLT REFILL A1 | EBF | Substantially Equivalent | Heraeus Kulzer, LLC | accessdata.fda.gov |
| December 14, 2011 | K112057 | KDL SYRINGES AND NEEDLE | FMF | Substantially Equivalent | Shanghai Kindly Enterprise Dev. Group Co., | accessdata.fda.gov |
| December 9, 2011 | K112946 | ACTIV VARNISH | LBH | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| November 29, 2011 | K111087 | FOUNDATION | LYC | Substantially Equivalent | Olympus Terumo Biomaterials Corporation | accessdata.fda.gov |
| November 18, 2011 | K111290 | PIEZO BONE SURGERY | DZI | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| November 17, 2011 | K111982 | CLEARFIL DC CORE PLUS | EBF | Substantially Equivalent | Kuraray America, Inc. | accessdata.fda.gov |
| October 28, 2011 | K112445 | SOFRELINER TOUGH S | EBI | Substantially Equivalent | Tokuyama Dental Corporation | accessdata.fda.gov |
| October 28, 2011 | K112250 | CHX=CHX PLUS | KJJ | Substantially Equivalent | Inter-Med, Inc. | accessdata.fda.gov |
| October 14, 2011 | K111958 | TETRIC EVOCERAM BULK FILL | EBF | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| September 23, 2011 | K112517 | ULTRASEAL XT HYDRO | EBC | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| July 22, 2011 | K111348 | RE / STASIS (TM) GINGIVAL RETRACTION PASTE | MVL | Substantially Equivalent | Centrix, Inc. | accessdata.fda.gov |
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Updated January 31, 2025. 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.