# K181858: Electric Handpiece Motor

- Pathway: 510(k) (Traditional)
- Applicant: W&H Dentalwerk Buermoos GmbH
- Decided: Mar 26, 2019 after 257 days
- Product code: EBW (Controller, Foot, Handpiece And Cord)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K983183 (1998). 10 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133776: A-Dec/W&H Electric Handpiece Motor, A-Dec, Inc. (2014) Summary page 4.
- K070663: A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97,  a-Dec/W&H Synea Handpiece Attachment, A-Dec, Inc. (2007) Summary page 4.
- K162926: Air-Powered Handpieces and Handpiece Attachments, W&H Dentalwerk Burmoos GmbH (2017) Summary page 4.

## Most influential descendants
- K213022: CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED (2022), 1 descendant of its own
- K233288: NLZ Built-In Motor System (2024), 0 descendants of its own
- K230895: CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4, (2024), 0 descendants of its own
- K231864: Fiber Optic Brushless Electronic Micromotor, model: iM100 (2024), 0 descendants of its own

## Indications for use
Electric Handpiece Motor EM-12 L is a brushless DC electric micromotor controlled by a control unit. The electrical drive, EM-12 L is indicated for use in the field of preventive dentistry, restorative applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.

Source page: https://510kreport.com/device/K181858
Methodology: https://510kreport.com/methodology