# K082716: A-Dec/W&H Alegra Air-Driven Highspeed Handpiece, Model TE-97, TE-98, a-Dec/W&H Alegra Handpiece Attachment, Model HE-43

- Pathway: 510(k) (Abbreviated)
- Applicant: A-Dec, Inc.
- Decided: Jan 15, 2009 after 120 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K120218: Tek Usa E-Generator Integrated Led Handpiece (High & Low Speed Air Turbnine Dental Handpiece) (2012), 0 descendants of its own

## Indications for use
The A-dec/W&H Alegra Air-Driven Highspeed Haridpiece is an air-powered dental handpiece for use in general dentistry. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. The A-dec/W&H Alegra Handpiece Attachment is powered by either an air-motor or electric micromotor for use in general dentistry. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth.

Source page: https://510kreport.com/device/K082716
Methodology: https://510kreport.com/methodology