510(k) · Cleared

Cleared

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

K120218510(k) TraditionalCleared Jun 29, 2012156-day reviewClass I21 CFR 872.4200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Palm Beach Dental Supply D/B/A Tek USA · EFB Handpiece, Air-Powered, Dental

Cleared on Jun 29, 2012 as substantially equivalent to K082716 (A-Dec, Inc., 2009) after a 156-day review. Its family tree reaches back 1 generation to 2009.

Decided: Jun 29, 2012
Review: 156 days
Class: Class I
Product code: EFB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K082716 (2009). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK082716 A-Dec/W&H Alegra Air-Driven Highspeed Handpiece, Model TE-97, TE-98…A-Dec, Inc. · 2009
This deviceK120218 Tek Usa E-Generator Integrated Led Handpiece (High & Low Speed Air…Palm Beach Dental Supply D/B/A Tek USA · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K082716	A-Dec/W&H Alegra Air-Driven Highspeed Handpiece, Model TE-97, TE-98, a-Dec/W&H…	A-Dec, Inc.	2009	—
0 (this device)	K120218	Tek Usa E-Generator Integrated Led Handpiece (High & Low Speed Air Turbnine…	Palm Beach Dental Supply D/B/A Tek USA	2012	—

FIG. 1 — Lineage of K120218, 2009–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EFB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new EFB device

#1 K262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED…score 13.3 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K082716	A-Dec/W&H Alegra Air-Driven Highspeed Handpiece, Model TE-97, TE-98, a-Dec/W&H Alegra… Summary page 2 …kzo I~ TEW, Predicate Device: Predicate 510(k): K082716 Trade name: W&H Alegra Air-Driven Highspeed Handpiece Product Code: EFE ('Handpiece, Airpowered, Dental")…	A-Dec, Inc.	2009	—
†	K021504	Tuttnauer Ehs Series Table-Top Autoclave, Model 2540	Tuttnauer U.S.A Co, Ltd.	2002	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.

How does its category compare?

All EFB devices

EFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · EFB

1in 2025

2007high 12 (2007) · low 1 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EFB

209in 2024

2007high 430 (2022) · low 61 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EFB

No recall names EFB since 2007.

Adverse event reports per year · EFB

83in 2025

2007high 157 (2022) · low 13 (2007)2025

MAUDE reports naming product code EFB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	12	61	13
2008	7	97	19
2009	11	120	40
2010	8	116	78
2011	4	168	96
2012	8	130	97
2013	3	207	61
2014	7	200	73
2015	7	296	87
2016	3	205	122
2017	7	246	153
2018	3	210	81
2019	3	348	117
2020	5	259	94
2021	2	—	123
2022	5	430	157
2023	4	158	116
2024	5	209	104
2025	1	—	83
2026	4	252	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120218 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120218: Tek Usa E-Generator Integrated Led Handpiece (High & Low Speed Air Turbnine Dental Handpiece).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120218

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026