# K983168: Avant High Speed Handpiece, Avant Fiber Optic High Speed Handpiece, Model #'S Avant HS 100 & Avant HS 200

- Pathway: 510(k) (Traditional)
- Applicant: Ora Innovations, Inc.
- Decided: Nov 18, 1998 after 69 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 K963050 (1996). 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)
- K963050: Tradition P, Push Button Handpiece, Midwest Dental Products Corp. (1996) Summary page 1.

## Indications for use
The Avant handpiece will be used by dentists to remove decayed tooth structure, and to cut or alter the shape of teeth so they may be restored to form and function.

Source page: https://510kreport.com/device/K983168
Methodology: https://510kreport.com/methodology