# K083811: W&H Handpiece Anesto, Model: RA-5

- Pathway: 510(k) (Traditional)
- Applicant: W&H Dentalwerk Buermoos GmbH
- Decided: Jan 14, 2010 after 388 days
- Product code: EGM (Injector, Jet, Mechanical-Powered)
- Device class: 2
- Regulation: 21 CFR 872.4475
- 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 K910446 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964802: Cyberjet Local Anesthesia System, Intra Vantage, Inc. (1997) Summary page 1.
- (no number) IntraFlow HTP: named in the summary without a submission number

## Most influential descendants
- K243427: QuickSleeper 5 (2025), 0 descendants of its own

## Indications for use
Drilling system to perforate cortical bane in order to administer local anesthesia in spongiosa. Application in dentistry.

Source page: https://510kreport.com/device/K083811
Methodology: https://510kreport.com/methodology