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 |
|---|---|---|---|
| K262084 | S.I.N. Instruments Kits | S.I.N. Implant System Ltda | 2026-10-22 |
| K262042 | Sterilization Cassette (CASS-1) | Alliedstar Medical Equipment Co., Ltd. | 2026-10-14 |
| K253988 | LiteSet Trays | Nobel Biocare AB | 2026-09-08 |
| K261935 | Surgical and Prosthetic Trays | Dentsply Sirona, Inc. | 2026-09-04 |
| K253187 | SteriBest® Sterilization Tray System | Mastel Surgical | 2026-06-18 |
| K252854 | SteriTite Container System with MediTray Products | Case Medical, Inc. | 2026-06-03 |
| K260726 | Straumann® ProClean™ Cassette (041.800 ; 041.801) | Institut Straumann AG | 2026-06-03 |
| 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 |
| K243425 | Guided DAS Surgical Kit | Talladium España, SL | 2025-07-22 |
| K251300 | Plastic Surgical Kits | Dentsply Sirona, Inc. | 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00385640095358 | INSTRUSAFE | Summit Medical, Inc. | 2026-10-28 |
| 00385640095341 | INSTRUSAFE | Summit Medical, Inc. | 2026-10-28 |
| 07899995224002 | SURGICAL KIT VERSALIS | Sin Sistema de Implante Nacional S/A | 2026-10-28 |
| 00385640095365 | INSTRUSAFE | Summit Medical, Inc. | 2026-10-28 |
| G476ISTO20X10X2 | ISTO BIOLOGICS SteriZign Sterilization Tray | Sterizign Precision Technologies, LLC | 2026-10-27 |
| 00385640095327 | INSTRUSAFE | Summit Medical, Inc. | 2026-10-26 |
| 00385640095334 | INSTRUSAFE | Summit Medical, Inc. | 2026-10-26 |
| 03701045278962 | KONTACT | BIOTECH DENTAL | 2026-10-26 |
| 03701045278979 | KONTACT | BIOTECH DENTAL | 2026-10-26 |
| 06973993446022 | Sterilization Cassette | Alliedstar Medical Equipment Co., Ltd. | 2026-10-26 |
| 00642356006772 | Mastel Surgical | Mastel Surgical Inc. | 2026-10-23 |
| 00642356006789 | Mastel Surgical | Mastel Surgical Inc. | 2026-10-23 |
| 00642356006796 | Mastel Surgical | Mastel Surgical Inc. | 2026-10-23 |
| 00642356006802 | Mastel Surgical | Mastel Surgical Inc. | 2026-10-23 |
| 00642356006819 | Mastel Surgical | Mastel Surgical Inc. | 2026-10-23 |
| 00642356006826 | Mastel Surgical | Mastel Surgical Inc. | 2026-10-23 |
| 00642356006833 | Mastel Surgical | Mastel Surgical Inc. | 2026-10-23 |
| 00642356006840 | Mastel Surgical | Mastel Surgical Inc. | 2026-10-23 |
| 00642356006857 | Mastel Surgical | Mastel Surgical Inc. | 2026-10-23 |
| 00642356006864 | Mastel Surgical | Mastel Surgical Inc. | 2026-10-23 |
| 00642356006765 | Mastel Surgical | Mastel Surgical Inc. | 2026-10-23 |
| 00642356006758 | Mastel Surgical | Mastel Surgical Inc. | 2026-10-23 |
| 00642356006734 | Mastel Surgical | Mastel Surgical Inc. | 2026-10-23 |
| 00642356006710 | Mastel Surgical | Mastel Surgical Inc. | 2026-10-23 |
| 00642356006703 | Mastel Surgical | Mastel Surgical Inc. | 2026-10-23 |
| 00642356006697 | Mastel Surgical | Mastel Surgical Inc. | 2026-10-23 |
| 00642356006680 | Mastel Surgical | Mastel Surgical Inc. | 2026-10-23 |
| 00642356006673 | Mastel Surgical | Mastel Surgical Inc. | 2026-10-23 |
| 00385640095310 | INSTRUSAFE | Summit Medical, Inc. | 2026-10-23 |
| 00385640095303 | INSTRUSAFE | Summit Medical, Inc. | 2026-10-23 |