# K080939: Surgical Handpieces, Mikro Saw Handpieces

- Pathway: 510(k) (Traditional)
- Applicant: W&H Dentalwerk Buermoos GmbH
- Decided: Jul 29, 2008 after 117 days
- Product code: KMW (Handpiece, Rotary Bone Cutting)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002469 (2001). 3 ancestors in all.
3 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)
- K011061: Surgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92 E/3,Surgical Straight Handpieces Types, S-9, S-10, S-11, W&H Dentalwerk Buermoos GmbH (2001) Summary page 1.
- K052741: Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl. Accessories, W&H Dentalwerk Buermoos GmbH (2006) Summary page 1.

## Most influential descendants
- K111532: Montblanc Surgical Contra-Angle and Straight Handpiece (2011), 1 descendant of its own
- K171155: Surgical Angle Handpiece, Surgical Straight Handpiece (2017), 0 descendants of its own
- K102241: Anthogyr Implanteo Implantology and Dental Surgical Motor Unit (2011), 0 descendants of its own

## Recalls of this device
- Jan 16, 2024 · Class II · Z-1168-2024: 1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead it reads 1:1 on the body of the handpiece

## Indications for use
Surgical treatment of dental hard tissue in oral and maxillo-facial surgery

Source page: https://510kreport.com/device/K080939
Methodology: https://510kreport.com/methodology