# K231087: Guided Surgery Kit

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct Sybron Manufacturing, LLC
- Decided: Aug 16, 2023 after 121 days
- Product code: DZI (Drill, Bone, Powered)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K894844 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200265: Surgical Drills, Implant Direct Sybron Manufacturing, LLC (2020) Summary page 4.

## Indications for use
The Guided Surgery Kit is designed to hold various dental surgical drills and instruments to organize, steam sterilize, and transport between uses. The guided surgical drills are intended to cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement. The kit is to be enclosed in a FDA cleared steam sterilizable wrap (maximum thickness KC300) and sterilized in a FDA cleared sterilizer for one of the following cycles: (1) Prevacuum Steam – At 132°C for 4 minutes with a 20 minute dry time. (2) Gravity Steam – At 132°C for 15 minutes with a 30 minute dry time. • The kit is intended for sterilization of non-porous loads. • Do not stack kits during sterilization. • Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Sterilizable Guided kit.

Source page: https://510kreport.com/device/K231087
Methodology: https://510kreport.com/methodology