Standard Surgical Kit
The FDA table identifies the Standard Surgical Kit as model CSSK and lists capacity for 46 instruments with a maximum load of 667.52 grams. This perforated instrument cassette is intended…
The FDA table identifies the Standard Surgical Kit as model CSSK and lists capacity for 46 instruments with a maximum load of 667.52 grams.
This perforated instrument cassette is intended to hold dental instruments in place during transport, steam sterilization and storage.
Listed Item
Drills & Tools (Qty 23) Tray & Pan (Qty1)
Configuration and Use
The filing says the Standard Sterilizable Tray may be supplied empty or loaded with surgical and prosthetic instruments. For the Standard Surgical Kit, the table gives the model-specific instrument capacity and maximum load; these figures describe the tray configuration rather than the instruments themselves.
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 | Implant Direct Sybron Manufacturing LLC, United States |
|---|---|
| FDA product code | KCT |
| Device type | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K202524 |
| Record published | 2021-04-12 |
| Record revised | 2023-04-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CSSK | 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 |
|---|---|
| K202524 | 2021-01-28 |
| K200858 | 2020-08-06 |
| K142519 | 2015-04-15 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-05-01 | Class II | Under Investigation by firm | The Drill stop kit contains incorrect components. | 45 Kits |
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.