Glidewell HT™
Glidewell HT Autoclavable Cassette organizes and protects dental surgical instruments during sterilization, storage and transport. Its lid, base and tray form a latched unit, with silicone…
Glidewell HT Autoclavable Cassette organizes and protects dental surgical instruments during sterilization, storage and transport. Its lid, base and tray form a latched unit, with silicone grommets holding the instruments in place.
The main components are polyphenylsulfone, and perforations permit moist-heat penetration. Instrument descriptions on the tray assist organization and positioning within the kit.
Listed Item
Autoclavable Cassette for Glidewell HT™ Implant Guided Surgical Kit
Sterilization Conditions
The guided surgical cassette accommodates up to 63 instruments and a validated full load of 641 g. Prevacuum steam sterilization is specified at 132°C for four minutes followed by 30 minutes drying. A validated sterilization wrap is required to maintain 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 | Prismatik Dentalcraft, Inc., 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 | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K242564 |
| Record published | 2025-04-21 |
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, manufacturing date |
| Storage | Special storage condition: Store in dry place at room temperature. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 70-1071-SRG0395 | 212mm x 173mm x 64mm | In distribution |
| 70-1071-SRG0397 | 212mm x 173mm x 64mm | In distribution |
| 70-1071-SRG0396 | 199mm x 174mm x 60mm | In distribution |
| 70-1071-SRG0398 | 199mm x 174mm x 60mm | 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 |
|---|---|
| K242564 | 2025-03-21 |
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.