# K090260: Modification to:Straumann Guided Instruments

- Pathway: 510(k) (Special)
- Applicant: Straumann Manufacturing, Inc.
- Decided: Feb 26, 2009 after 23 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- 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.
No later device cites it as a predicate yet.
0 of 3 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 1.

## 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/K090260
Methodology: https://510kreport.com/methodology