# K984244: Orl-E-92 Surgical Drill System

- Pathway: 510(k) (Traditional)
- Applicant: Bien Air USA, Inc.
- Decided: Feb 23, 1999 after 88 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- 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: 1 generation back to K792159 (1979). 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)
- K934783: Kavo Intrasept 905, Kavo America (1994) Summary page 1.
- K792159: Fisch Drill System, Jedmed Instrument Co. (1979) Summary page 1.

## Most influential descendants
- K031540: Apex Electric Handpiece System (2003), 0 descendants of its own

## Indications for use
The Bien-Air ORL-E-92 Surgical Drill System is indicated for the preparation of intraoral bone for microsurgery and implantology and for apicoectomies.

Source page: https://510kreport.com/device/K984244
Methodology: https://510kreport.com/methodology