# K082532: Straumann Guided Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA
- Decided: Oct 21, 2008 after 49 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: 1 generation back to K894844 (1990). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894844: Bonefit Implant System Accessories & Instruments, Straumann Institute, Ltd. (1990) Summary page 1.

## Most influential descendants
- K200265: Surgical Drills (2020), 1 descendant of its own
- K231087: Guided Surgery Kit (2023), 0 descendants of its own
- K090260: Modification to:Straumann Guided Instruments (2009), 0 descendants of its own

## Indications for use
Bone cutting instruments are intended for use during oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin or screw.

Source page: https://510kreport.com/device/K082532
Methodology: https://510kreport.com/methodology