FDA Product Code
FDA Product Code KCT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6850
510(k) Clearances — 282 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253988 | LiteSet Trays | Nobel Biocare AB | 2026-09-08 | Traditional | PDF ↗ |
| K261935 | Surgical and Prosthetic Trays | Dentsply Sirona, Inc. | 2026-09-04 | Traditional | PDF ↗ |
| K253187 | SteriBest® Sterilization Tray System | Mastel Surgical | 2026-06-18 | Traditional | PDF ↗ |
| K252854 | SteriTite Container System with MediTray Products | Case Medical, Inc. | 2026-06-03 | Traditional | PDF ↗ |
| K260726 | Straumann® ProClean Cassette (041.800 ; 041.801) | Institut Straumann AG | 2026-06-03 | Traditional | PDF ↗ |
| K253791 | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid | DePuy Mitek, Inc. | 2026-02-26 | Traditional | PDF ↗ |
| K251614 | Stainless Steel Surgical Kits | Dentsply Sirona, Inc. | 2026-02-06 | Traditional | PDF ↗ |
| K251756 | Sterilization Trays | Paragon Implant Mfg., LLC | 2025-11-14 | Traditional | PDF ↗ |
| K243425 | Guided DAS Surgical Kit | Talladium España, SL | 2025-07-22 | Traditional | PDF ↗ |
| K251300 | Plastic Surgical Kits | Dentsply Sirona, Inc. | 2025-07-22 | Traditional | PDF ↗ |
| K243589 | PAL Sterilization Case | Microaire Surgical Instruments, LLC | 2025-06-20 | Traditional | PDF ↗ |
| K242762 | Aesculap Aicon® Series Container System | Aesculap, Inc. | 2025-05-13 | Traditional | PDF ↗ |
| K250029 | ONE TRAY® Sealed Sterilization Container System | Innovative Sterilization Technologies | 2025-05-01 | Traditional | PDF ↗ |
| K241927 | Synthes Graphic Case & Tray System | Synthes GmbH | 2025-03-28 | Traditional | PDF ↗ |
| K242564 | Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthetic Kit) | Prismatik Dentalcraft, Inc. | 2025-03-21 | Traditional | PDF ↗ |
| K242023 | Microdent Sterilization Cassette | Implant Microdent System S.L.U. | 2025-02-19 | Traditional | PDF ↗ |
| K243317 | NUVENTUS NV.C Surgical Cassette and Tray | Infinitum Eta, Ltd. | 2025-02-11 | Traditional | PDF ↗ |
| K242834 | System 9 Sterile Battery Container | Stryker Instruments | 2025-01-16 | Traditional | PDF ↗ |
| K243128 | Klockner Kits | SOADCO, S.L. | 2024-12-18 | Traditional | PDF ↗ |
| K241492 | Guided Surgery Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2024-08-23 | Traditional | PDF ↗ |
| K240898 | SteriTite rigid reusable sterilization container with MediTray Products | Case Medical | 2024-07-31 | Traditional | PDF ↗ |
| K241050 | CrossRoads Modular Tray System | Crossroads Extremity Systems | 2024-07-16 | Traditional | PDF ↗ |
| K241378 | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. | 2024-07-12 | Traditional | PDF ↗ |
| K231291 | Perforated Baskets | Richard Wolf Medical Instruments Corporation | 2024-06-03 | Traditional | PDF ↗ |
| K233578 | BAHADIR STERILIZATION CONTAINERS | Bahadir USA, LLC | 2024-03-22 | Traditional | PDF ↗ |
| K231144 | Washtrays | Dentsply Sirona | 2024-01-16 | Traditional | PDF ↗ |
| K233264 | Anthogyr INTEGRAL Guided Surgery Cassettes | Anthogyr | 2023-12-22 | Traditional | PDF ↗ |
| K233222 | Aygün Sterilization Container Systems | Aygun Surgical Instruments Co., Inc. | 2023-12-12 | Traditional | PDF ↗ |
| K231604 | Instrument Case | Cochlear Americas | 2023-08-24 | Special | PDF ↗ |
| K231501 | PRO-LITE Sterilization Tray | STERIS Corporation | 2023-08-07 | Traditional | PDF ↗ |
| K230680 | Anthogyr Surgical Cassettes | Anthogyr | 2023-07-11 | Traditional | PDF ↗ |
| K230804 | Complement Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2023-07-07 | Traditional | PDF ↗ |
| K231219 | NobelZygoma PureSet Tray | Nobel Biocare Services AG | 2023-06-27 | Traditional | PDF ↗ |
| K222640 | Sweden & Martina Surgical Trays | Sweden & Martina S.P.A. | 2023-05-26 | Traditional | PDF ↗ |
| K223662 | Neodent Implant System - Helix Short Surgical Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2023-04-20 | Traditional | PDF ↗ |
| K223672 | Instrument Case P1340904 | Cochlear | 2023-03-21 | Traditional | PDF ↗ |
| K214041 | Aesculap AICON Container | Aesculap, Inc. | 2022-12-30 | Traditional | PDF ↗ |
| K222514 | S.I.N. Instrument Kits | S.I.N. Sistema DE Implante Nacional S.A. | 2022-10-27 | Traditional | PDF ↗ |
| K221492 | SteriTite Container System with MediTray Parts | Case Medical, Inc. | 2022-10-07 | Traditional | PDF ↗ |
| K222005 | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. | 2022-09-29 | Traditional | PDF ↗ |
| K222328 | SteriCUBE® Multiple Tray Sterilization Systems | Stericube, LLC | 2022-09-28 | Traditional | PDF ↗ |
| K220791 | Surgical and Prosthetic Trays | Dentsply Sirona | 2022-05-03 | Traditional | PDF ↗ |
| K212711 | SteriTite Container System with MediTray Products | Case Medical, Inc. | 2022-04-29 | Traditional | PDF ↗ |
| K214051 | Neodent Implant System-Helix NGM Compact Surgical Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2022-04-13 | Traditional | PDF ↗ |
| K212281 | Surgical Trays | Dentsply Sirona, Inc. | 2022-03-04 | Traditional | PDF ↗ |
| K210923 | Southern Implants Instrument Trays | Southern Implants (Pty), Ltd. | 2022-03-02 | Traditional | PDF ↗ |
| K203177 | Sterisystem Dry-Base Instrument Tray | O&M Halyard, Inc. | 2022-01-02 | Traditional | PDF ↗ |
| K213209 | EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device | K1 Medical, LLC | 2021-12-28 | Traditional | PDF ↗ |
| K203468 | TCAT TKA Instrument Tray | THINK Surgical, Inc. | 2021-12-20 | Traditional | PDF ↗ |
| K212932 | Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray | Nobel Biocare Services AG | 2021-12-18 | Traditional | PDF ↗ |
| K210836 | InstruSafe Instrument Protection System | Summitt Medical, LLC | 2021-11-30 | Traditional | PDF ↗ |
| K212068 | Biotech Dental Kits | Biotech Dental, Sas | 2021-11-08 | Traditional | PDF ↗ |
| K212404 | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. | 2021-11-03 | Traditional | PDF ↗ |
| K212396 | UroLift System Rigid Retrieval Kit Sterilization Tray | Neotract, Inc. | 2021-10-22 | Special | PDF ↗ |
| K203492 | Instrument tray, for semi-rigid ureteroscope | Olympus Winter & Ibe GmbH | 2021-09-15 | Traditional | PDF ↗ |
| K203753 | Straumann Surgical Cassettes | Straumann USA, LLC | 2021-07-29 | Traditional | PDF ↗ |
| K203198 | KARL STORZ Metal Sterilization Trays | Karl Storz Endoscopy America, Inc. | 2021-07-06 | Traditional | PDF ↗ |
| K211007 | EZ-TRAXTM Persona Knee Containment Device | K1 Medical, LLC | 2021-07-01 | Traditional | PDF ↗ |
| K203572 | Karl Storz Radel Sterilization Trays | Karl Storz Endoscopy America, Inc. | 2021-05-07 | Traditional | PDF ↗ |
| K201878 | ST-Z5 | Z-Systems AG | 2021-03-25 | Traditional | PDF ↗ |
| K203618 | Neodent EasyGuide Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2021-03-09 | Traditional | PDF ↗ |
| K201533 | Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes | Avinent Implant System S.L.U. | 2021-03-01 | Traditional | PDF ↗ |
| K201945 | KARL STORZ UDEL Sterilization Trays | Karl Storz Endoscopy America, Inc. | 2021-02-25 | Traditional | PDF ↗ |
| K201412 | BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO Semados Tr 58348, BEGO Semados DSTr 58356; Drill Stop Tray Plus (RS/RSX-Line), BEGO SEMADOS PKTr 58357; Prosthetic Kit | Bego Implant Systems GmbH & Co. KG | 2021-02-18 | Traditional | PDF ↗ |
| K202524 | Standard Sterilizable Tray | Implant Direct Sybron Manufacturing, LLC | 2021-01-28 | Traditional | PDF ↗ |
| K202268 | CrossRoads Tray System | Crossroads Extremity Systems, LLC | 2020-12-30 | Traditional | PDF ↗ |
| K202270 | EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device | K1 Medical, LLC | 2020-12-02 | Traditional | PDF ↗ |
| K202515 | NUVO Implant System NUVO Instrument Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020-11-24 | Traditional | PDF ↗ |
| K182084 | Sweden & Martina Surgical Tray (Model ZSHORTY-INT) | Sweden & Martina S.P.A. | 2020-11-04 | Traditional | PDF ↗ |
| K202105 | OsteoMed ExtremiFix Mini & Small System Tray | Osteomed, LLC | 2020-10-29 | Traditional | PDF ↗ |
| K201688 | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. | 2020-10-21 | Traditional | PDF ↗ |
| K200858 | Mini Sterilizable Tray | Implant Direct Sybron Manufacturing, LLC | 2020-08-06 | Traditional | PDF ↗ |
| K193066 | Steripack cases and Tray Systems | Avalign Technologies, Inc. | 2020-08-06 | Traditional | PDF ↗ |
| K193603 | Benesta Medical Sterilization Tray | Caldera Medical, Inc. | 2020-07-20 | Traditional | PDF ↗ |
| K192781 | UroLift System Procedure Kit Sterilization Tray | Neotract, Inc. | 2020-04-14 | Traditional | PDF ↗ |
| K200632 | TCAT TKA Instrument Tray Set | THINK Surgical, Inc. | 2020-04-08 | Special | PDF ↗ |
| K192056 | JJ Series Container System | Aesculap, Inc. | 2020-03-27 | Traditional | PDF ↗ |
| K193582 | SterilContainer S2 System | Aesculap, Inc. | 2020-03-17 | Traditional | PDF ↗ |
| K191566 | Avinent Surgical Tray | Avinent Implant System S.L.U. | 2020-03-06 | Traditional | PDF ↗ |
| K192487 | EZ-TRAX Containment Device | K1 Medical, LLC | 2019-12-23 | Traditional | PDF ↗ |
| K190665 | Neodent Instrument Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-12-23 | Traditional | PDF ↗ |
| K192670 | Neodent Instrument Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-12-18 | Traditional | PDF ↗ |
| K191522 | Straumann Modular Cassette | Institut Straumann AG | 2019-12-03 | Traditional | PDF ↗ |
| K181845 | Pivot System Sterilization case | Rp Medical, Inc. | 2019-11-25 | Traditional | PDF ↗ |
| K190541 | MTS225 and MTS300 Multiple Tray Sterilization Systems | Pmbs, LLC | 2019-11-05 | Traditional | PDF ↗ |
| K190840 | Medtronic Transportation / Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2019-10-15 | Traditional | PDF ↗ |
| K191475 | Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate | Nobel Biocare AB | 2019-08-29 | Traditional | PDF ↗ |
| K182414 | Aesculap® SterilContainer(TM) S2 System | Aesculap, Inc. | 2019-07-05 | Traditional | PDF ↗ |
| K190667 | Sonopet iQ Sterilization Tray | Paragon Medical | 2019-06-13 | Traditional | PDF ↗ |
| K181933 | DePuy Synthes Sterilization Container System | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2019-05-09 | Traditional | PDF ↗ |
| K183701 | Stryker ChestShield Sterilization Tray System | Paragon Medical | 2019-05-07 | Traditional | PDF ↗ |
| K182865 | Neodent Instruments Kits | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-05-07 | Traditional | PDF ↗ |
| K180127 | TCAT (R) THA Instrument Tray Set | THINK Surgical, Inc. | 2019-03-15 | Traditional | PDF ↗ |
| K183402 | PRO-LITE Sterilization Tray | STERIS Corporation | 2019-03-01 | Traditional | PDF ↗ |
| K182052 | Omni Instrument Tray | Hologic, Inc. | 2019-02-26 | Traditional | PDF ↗ |
| K183139 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | 2019-02-01 | Abbreviated | PDF ↗ |
| K183301 | PRO-LITE Sterilization Tray | STERIS Corporation | 2019-01-03 | Traditional | PDF ↗ |
| K182032 | SterilContainer S System | Aesculap, Inc. | 2018-12-21 | Traditional | PDF ↗ |
| K180528 | InstruSafe(R) Sterilization Container | Summit Medical, Inc. | 2018-11-16 | Traditional | PDF ↗ |
| K173642 | KLOCKNER SURGICAL BOX | SOADCO, S.L. | 2018-10-02 | Abbreviated | PDF ↗ |
Product code KCT · Class II · General Hospital. Data: openFDA.