# K200265: Surgical Drills

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct Sybron Manufacturing, LLC
- Decided: Jun 30, 2020 after 148 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: 2 generations back to K894844 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082532: Straumann Guided Instruments, Straumann USA (2008) Summary page 4.

## Most influential descendants
- K231087: Guided Surgery Kit (2023), 0 descendants of its own

## Indications for use
The Surgical Drills are intended to cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement.

Source page: https://510kreport.com/device/K200265
Methodology: https://510kreport.com/methodology