# K120218: Tek Usa E-Generator Integrated Led Handpiece (High & Low Speed Air Turbnine Dental Handpiece)

- Pathway: 510(k) (Traditional)
- Applicant: Palm Beach Dental Supply D/B/A Tek USA
- Decided: Jun 29, 2012 after 156 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 K082716 (2009). 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)
- 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, A-Dec, Inc. (2009) Summary page 2.

## Indications for use
The TEK USA Airdriven LED handpiece with Integrated F-Generator is indicated for use by a trained dental professional authorized in the practice of general dentistry. These dental handpiece devices are available in both high and low speed and are designed for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations/restorations, polishing teeth and other procedures that are considered within the space of dental prophylaxis.

Source page: https://510kreport.com/device/K120218
Methodology: https://510kreport.com/methodology