# K954690: Stryker Oral Max System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Aug 20, 1996 after 314 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) powered instruments, controls, and associated accessories marketed by Stryker prior to the 1976 Medical Devices Amendment: named in the summary without a submission number
- (no number) power sources distributed by Aseptico: named in the summary without a submission number

## Most influential descendants
- K062842: Twist Drill (2006), 5 descendants of its own
- K213072: 2.1 x 255mm Drill, 22mm Stop (2022), 1 descendant of its own
- K223199: 2.1 x 255mm Drill, 22mm Stop (2022), 0 descendants of its own
- K213208: Twist Drills (2021), 0 descendants of its own
- K170442: Cranial Drill Bits and Accessories (2017), 0 descendants of its own

## Indications for use
The Oral Max System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures including but not limited to, dental and oral surgery It is also usable in the placement of screws.

Source page: https://510kreport.com/device/K954690
Methodology: https://510kreport.com/methodology