Stainless Steel Surgical Kits

The Stainless Steel Surgical Kits are reusable stainless steel containers designed to organize, sterilize, and store drills, instruments, and prosthetic accessories used in dental implant procedures. They come in two types: closed kits with a removable insert and closable perforated lid, and open kits with integrated holders and a removable base. The kits are not intended to maintain sterility themselves and must be used with an FDA-cleared sterilization pouch.

The proposed device shares the same intended use, sterilization method (pre-vacuum steam at 132°C for 4 minutes), and fundamental design as the predicate Surgical and Prosthetic Trays (K220791). Both are reusable, non-sterile devices made of stainless steel with silicone holders. The main difference is the proposed kit's validated reuse life of 50 cycles compared to the predicate's 200 cycles, and the proposed device accommodates fewer instruments (5-20 vs. 22-56).

ISO 17665:2024, ANSI/AAMI ST98:2022, AAMI TIR 12:2020/(R) 2023, ISO 10993-5:2009/(R)2022, ASTM D4332-22, ASTM D4169-23e1.

The proposed Stainless Steel Surgical Kits are substantially equivalent to the predicate device because they have the same intended use, identical sterilization parameters and method, comparable materials (stainless steel and silicone), and similar general design and functionality. Non-clinical testing demonstrates the device is safe and effective for organizing, sterilizing, and storing surgical instruments, with passing results for cleaning, sterilization, service life, transportation, and cytotoxicity across all validation studies.