Straumann Modular Cassette
Straumann Modular Cassette is a system for organizing, enclosing, sterilizing, transporting and storing dental instruments between procedures. Its A, B and C modules hold removable trays or…
Straumann Modular Cassette is a system for organizing, enclosing, sterilizing, transporting and storing dental instruments between procedures. Its A, B and C modules hold removable trays or fixed supports for different instrument arrangements.
Silicone strips and holders keep instruments in position during surgery and sterilization. Printed pictograms and colour-coded workflows identify instrument positions and help organize the sequence of use.
Listed Item
Straumann iGuide™ B Module for T-sleeve Ø 5.2mm, BLC/BLX and TLC/TLX, PPSU/silicone
Modules and Sterile Packaging
Module A holds multiple removable trays, Module B holds one workflow tray and Module C has fixed silicone supports. Module A is sterilized individually; permitted B/C stacks follow the specified load arrangement. The cassette requires a validated double pouch to maintain the instruments’ sterility.
Who Else Makes It
Concentrated in Jiangsu (2), Shandong (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Lianyungang Anson Non-woven Product Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 13 |
| Medipack Medical Packaging MFG. Co. | Dongguan | Guangdong | Contract manufacturer | 5 |
| AR Medicom Inc., (Asia), Ltd. | Hongkong | Hong Kong | Exporter | 5 |
| Wipak Packaging (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Institut Straumann AG, Switzerland |
|---|---|
| FDA product code | KCT |
| Device type | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K191522 |
| Record published | 2024-05-03 |
| Record revised | 2026-01-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight |
| Sizes | Outer diameter 5.2 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | Outer Diameter 5.2 mm | In distribution |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution | |
| Storage Systems / Cassettes | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrusafe | Summit Medical LLC | 6,357 |
| V. Mueller | Steris Corporation | 1,080 |
| Ermis | Ermis MedTech | 597 |
| Bahadir USA | Bahadir USA LLC | 561 |
| Avalign | Avalign Technologies, Inc. | 447 |
| Sklar® | Sklar Corporation | 363 |
| HNM Medical | HNM Stainless, LLC. | 337 |
| Surgical Instrument | SIN Sistema DE Implante Nacional S.A | 295 |
| ReLine | Nuvasive, Inc. | 290 |
| Case Medical | Case Medical, Inc. | 289 |
| Millennium | Avalign Technologies, Inc. | 268 |
| V. Mueller | Carefusion 2200, Inc. | 174 |
Showing 12 of 599. All products under Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260726 | 2026-06-03 |
| K191522 | 2019-12-03 |
| K180791 | 2018-06-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.