Product code KCT
- Device name
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.6850
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253791 | PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid | DePuy Mitek, Inc. | 2026-02-26 |
| K251614 | Stainless Steel Surgical Kits | Dentsply Sirona, Inc. | 2026-02-06 |
| K251756 | Sterilization Trays | Paragon Implant Mfg., LLC | 2025-11-14 |
| K251300 | Plastic Surgical Kits | Dentsply Sirona, Inc. | 2025-07-22 |
| K243425 | Guided DAS Surgical Kit | Talladium España, SL | 2025-07-22 |
| K243589 | PAL Sterilization Case | Microaire Surgical Instruments, LLC | 2025-06-20 |
| K242762 | Aesculap Aicon® Series Container System | Aesculap, Inc. | 2025-05-13 |
| K250029 | ONE TRAY® Sealed Sterilization Container System | Innovative Sterilization Technologies | 2025-05-01 |
| K241927 | Synthes Graphic Case & Tray System | Synthes GmbH | 2025-03-28 |
| K242564 | Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) | Prismatik Dentalcraft, Inc. | 2025-03-21 |
| K242023 | Microdent Sterilization Cassette | Implant Microdent System S.L.U. | 2025-02-19 |
| K243317 | NUVENTUS NV.C™ Surgical Cassette and Tray | Infinitum Eta, Ltd. | 2025-02-11 |
| K242834 | System 9 Sterile Battery Container | Stryker Instruments | 2025-01-16 |
| K243128 | Klockner Kits | SOADCO, S.L. | 2024-12-18 |
| K241492 | Guided Surgery Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2024-08-23 |
| K240898 | SteriTite rigid reusable sterilization container with MediTray Products | Case Medical | 2024-07-31 |
| K241050 | CrossRoads Modular Tray System | Crossroads Extremity Systems | 2024-07-16 |
| K241378 | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. | 2024-07-12 |
| K231291 | Perforated Baskets | Richard Wolf Medical Instruments Corporation | 2024-06-03 |
| K233578 | BAHADIR STERILIZATION CONTAINERS | Bahadir USA, LLC | 2024-03-22 |
| K231144 | Washtrays | Dentsply Sirona | 2024-01-16 |
| K233264 | Anthogyr INTEGRAL Guided Surgery Cassettes | Anthogyr | 2023-12-22 |
| K233222 | Aygün Sterilization Container Systems | Aygun Surgical Instruments Co., Inc. | 2023-12-12 |
| K231604 | Instrument Case | Cochlear Americas | 2023-08-24 |
| K231501 | PRO-LITE Sterilization Tray | STERIS Corporation | 2023-08-07 |
| K230680 | Anthogyr Surgical Cassettes | Anthogyr | 2023-07-11 |
| K230804 | Complement Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2023-07-07 |
| K231219 | NobelZygoma PureSet™ Tray | Nobel Biocare Services AG | 2023-06-27 |
| K222640 | Sweden & Martina Surgical Trays | Sweden & Martina S.P.A. | 2023-05-26 |
| K223662 | Neodent Implant System - Helix Short Surgical Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2023-04-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810166522809 | X-PAC | EXPANDING INNOVATIONS, INC. | 2026-05-27 |
| 07640166769651 | Z5m(t)-neo Tray Full | Z-Systems AG | 2026-05-17 |
| 07640166769521 | Z5m(t)-neo Insert | Z-Systems AG | 2026-05-17 |
| 07640462720684 | NUVENTUS NV.C™ | InfinetaMed AG | 2026-05-13 |
| 07640462720677 | NUVENTUS NV.C™ | InfinetaMed AG | 2026-05-13 |
| 07640462720660 | NUVENTUS NV.C™ | InfinetaMed AG | 2026-05-13 |
| 07640462720332 | NUVENTUS NV.C™ | InfinetaMed AG | 2026-05-13 |
| 07630031782298 | Straumann Modular Cassette | Institut Straumann AG | 2026-05-07 |
| 07899878058298 | Neodent | JJGC Indústria e Comércio de Materiais Dentários S/A. | 2023-06-15 |
| 07899878058281 | Neodent | JJGC Indústria e Comércio de Materiais Dentários S/A. | 2023-06-15 |
| 07630894804755 | APTUS | Medartis AG | 2023-02-24 |
| 07630894805585 | APTUS | Medartis AG | 2023-02-24 |
| 07630894805059 | APTUS | Medartis AG | 2023-02-24 |
| 07630894804946 | APTUS | Medartis AG | 2023-02-24 |
| 07630894804922 | APTUS | Medartis AG | 2023-02-24 |
| 07630894804830 | APTUS | Medartis AG | 2023-02-24 |
| 07630894804809 | APTUS | Medartis AG | 2023-02-24 |
| 07630894804717 | APTUS | Medartis AG | 2023-02-24 |
| 07630894804694 | APTUS | Medartis AG | 2023-02-24 |
| 07630894804670 | APTUS | Medartis AG | 2023-02-24 |
| 07630894804656 | APTUS | Medartis AG | 2023-02-24 |
| 07630894804564 | APTUS | Medartis AG | 2023-02-24 |
| 07630894804533 | APTUS | Medartis AG | 2023-02-24 |
| 07630037854487 | APTUS | Medartis AG | 2023-02-10 |
| 07630037854432 | APTUS | Medartis AG | 2023-02-10 |
| 07630037854333 | APTUS | Medartis AG | 2023-02-10 |
| 07630037854326 | APTUS | Medartis AG | 2023-02-10 |
| 07630037854296 | APTUS | Medartis AG | 2023-02-10 |
| 07630037850397 | MODUS | Medartis AG | 2023-02-10 |
| EZPF85327500 | HELMUT ZEPF | Helmut Zepf Medizintechnik GmbH | 2022-12-08 |