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510(k) Data Aggregation
(158 days)
The Sterilization Trays are designed to hold various dental surgical and prosthetic instruments to organize, steam sterilize and transport the instruments between uses. The kit is to be enclosed in an FDA cleared steam sterilizable pouch large enough to fit a tray, and sterilized in an FDA cleared sterilizer for the following cycles:
- Gravity Steam Cycle – At 132°C for 15 minutes with a 30-minute dry time
- Pre-vacuum Steam Cycle – At 132°C for 4 minutes with a 20-minute dry time
- The kits are intended for sterilization of non-porous loads
- The tested kit represents the worst-case validated load of 497.1 grams
Paragon sterilization trays are divided into the following types:
- Complete Surgical Kit
- Standard Surgical Kit
- Drill Stop Kit
- Prosthetic Kit
The Surgical, Drill Stop, and Prosthetic Kits are reusable perforated instrument cassette systems, composed of an outer case (base), cover (lid), and insert, that is designed to hold dental instruments in place during transport, steam sterilization, and storage. The Surgical Kits are designed to support Paragon implant/prosthetic placement protocols, as well as hold various dental instruments such as: Surgical Drills, Drill Stops, Paralleling Tools, Implant Drivers, Drill Extender, Prosthetic Drivers and Torque Wrenches. The insert contains markings and colors to indicate either the surgical workflow or the position of the instruments within the cassette.
The Standard Surgical Kit includes a removable stainless-steel pan, which functions as a storage receptacle for used surgical instruments.
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