# K253655: Angled Screwdriver MED (M-SD090)

- Pathway: 510(k) (Traditional)
- Applicant: W&H Dentalwerk Bürmoos GmbH
- Decided: Jul 31, 2026 after 253 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 K082649 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082649: Synthes 90 Degree Screwdriver, Synthes (Usa) (2009) Summary page 5.

## Indications for use
The surgical transmission instrument is indicated for: Drilling and screwing of osteosynthesis screws, implants and plate systems into organic hard tissue in oral/maxillofacial surgery.

Source page: https://510kreport.com/device/K253655
Methodology: https://510kreport.com/methodology