KCT
- Product code
- KCT
- Device name
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.6850
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 26
- Summaries archived here
- 19 (direct download)
- 510(k) clearances (all years, FDA)
- 280 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (26)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253187 | 2026-06-18 | Mastel Surgical | SteriBest® Sterilization Tray System | |
| K252854 | 2026-06-03 | Case Medical, Inc. | SteriTite Container System with MediTray Products | |
| K260726 | 2026-06-03 | Institut Straumann AG | Straumann® ProClean Cassette (041.800 ; 041.801) | |
| K253791 | 2026-02-26 | DePuy Mitek, Inc. | PUREVUE Quick Connect Cannula System Tray; PUREVUE… | |
| K251614 | 2026-02-06 | Dentsply Sirona, Inc. | Stainless Steel Surgical Kits | |
| K251756 | 2025-11-14 | Paragon Implant Mfg., LLC | Sterilization Trays | |
| K243425 | 2025-07-22 | Talladium España, SL | Guided DAS Surgical Kit | |
| K251300 | 2025-07-22 | Dentsply Sirona, Inc. | Plastic Surgical Kits | FDA |
| K243589 | 2025-06-20 | Microaire Surgical Instruments, LLC | PAL Sterilization Case | |
| K242762 | 2025-05-13 | Aesculap, Inc. | Aesculap Aicon® Series Container System | |
| K250029 | 2025-05-01 | Innovative Sterilization Technologies | ONE TRAY® Sealed Sterilization Container System | |
| K241927 | 2025-03-28 | Synthes GmbH | Synthes Graphic Case & Tray System | |
| K242564 | 2025-03-21 | Prismatik Dentalcraft, Inc. | Autoclavable Cassette (Glidewell HT Implant Guided … | FDA |
| K242023 | 2025-02-19 | Implant Microdent System S.L.U. | Microdent Sterilization Cassette | |
| K243317 | 2025-02-11 | Infinitum Eta, Ltd. | NUVENTUS NV.C Surgical Cassette and Tray | |
| K242834 | 2025-01-16 | Stryker Instruments | System 9 Sterile Battery Container | FDA |
| K243128 | 2024-12-18 | SOADCO, S.L. | Klockner Kits | |
| K241492 | 2024-08-23 | JJGC Indústria e Comércio de Materiais… | Guided Surgery Kit Cases | |
| K240898 | 2024-07-31 | Case Medical | SteriTite rigid reusable sterilization container wit… | FDA |
| K241050 | 2024-07-16 | Crossroads Extremity Systems | CrossRoads Modular Tray System | FDA |
| K241378 | 2024-07-12 | S.I.N. - Sistema DE Implante Nacional … | S.I.N. Instrument Kits | FDA |
| K231291 | 2024-06-03 | Richard Wolf Medical Instruments Corpo… | Perforated Baskets | |
| K233578 | 2024-03-22 | Bahadir USA, LLC | BAHADIR STERILIZATION CONTAINERS | |
| K231144 | 2024-01-16 | Dentsply Sirona | Washtrays | |
| K233264 | 2023-12-22 | Anthogyr | Anthogyr INTEGRAL Guided Surgery Cassettes | |
| K233222 | 2023-12-12 | Aygun Surgical Instruments Co., Inc. | Aygün Sterilization Container Systems | — |
Official FDA classification page: KCT
Classification and pathway per current FDA publications. Data from openFDA (CC0).