510(k) · Cleared

Cleared

Impact Air 45 Handpiece for Endodontic Use

K972375510(k) TraditionalCleared Sep 10, 199777-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

Glenwood, LLC · EFB Handpiece, Air-Powered, Dental

Cleared on Sep 10, 1997 as substantially equivalent to K760794 (Midwest, 1976) and 3 other predicates after a 77-day review. Its family tree reaches back 1 generation to 1976. 10 later devices descend from it.

Decided: Sep 10, 1997
Review: 77 days
Class: Class I
Product code: EFB
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K760794 (1976). 4 ancestors in all. 10 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK760794 Fiber Optics High Speed HandpieceMidwest · 1976
This deviceK972375 Impact Air 45 Handpiece for Endodontic UseGlenwood, LLC · 1997
Descendant · cites it directly · 9 of its ownK130455 430 SWL 45 and 430 SW 45 High-Speed HandpiecesDentalez Group, Stardental Division · 2013
Descendant · 2 generations on · 8 of its ownK152146 High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015
Descendant · 3 generations on · 4 of its ownK170229 Dental High-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017
Descendant · 4 generations on · 2 of its ownK181691 High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd. · 2020
Descendant · 5 generations on · 1 of its ownK220179 High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle…Foshan Coxo Medical Instrument Co., Ltd. · 2023

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2013high 2 (2020) · low 0 (2014)2026

Most influential descendants

Showing 5 of 10 · See all

K130455430 SWL 45 and 430 SW 45 High-Speed HandpiecesDentalez Group, Stardental Division · 2013 · cites it directly9descendants
K152146High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015 · 2 generations on8descendants
K170229Dental High-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017 · 3 generations on4descendants
K181691High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd. · 2020 · 4 generations on2descendants
K220179High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsFoshan Coxo Medical Instrument Co., Ltd. · 2023 · 5 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K760794	Fiber Optics High Speed Handpiece	Midwest	1976	—
0 (this device)	K972375	Impact Air 45 Handpiece for Endodontic Use	Glenwood, LLC	1997	—
+1	K130455	430 SWL 45 and 430 SW 45 High-Speed Handpieces	Dentalez Group, Stardental Division	2013	—
+2	K152146	High Speed Handpieces and Accessories	Codent Technical Industry Co., Ltd.	2015	—
+3	K170229	Dental High-speed Turbine Handpiece	Guangdong Jinme Medical Technology Co., Ltd.	2017	—
+4	K181691	High-speed air turbine handpiece / Low-speed air turbine handpiece	Foshan Wenjian Medical Instrument Co., Ltd.	2020	—
+5	K220179	High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle…	Foshan Coxo Medical Instrument Co., Ltd.	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1978	1	0
1986	1	0
1991	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2015	1	0
2017	1	0
2018	1	0
2020	2	0
2023	1	0
2024	2	0
2026	1	0

FIG. 1 — Lineage of K972375, 1976–2026Source: 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

Get a 510(k) Report

What was it cleared against? (4)

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
*	K760794	Fiber Optics High Speed Handpiece Summary page 1 …rade Name: Impact Air 45 Handpiece for Endodontic Use Classification Name: Dental Handpiece (21 C.F.R. §872.4200) Predicate Devices: “Fiber Optic High Speed Handpiece” (K760794) and “Tradition High Speed Handpiece” (K863677), both manufac- tured by Midwest; the “Dental Handpiece” (K780038) by Lares Manufa…	Midwest	1976	—
*	K863677	Tradition High Speed Handpiece Summary page 1 …ic Use Classification Name: Dental Handpiece (21 C.F.R. §872.4200) Predicate Devices: “Fiber Optic High Speed Handpiece” (K760794) and “Tradition High Speed Handpiece” (K863677), both manufac- tured by Midwest; the “Dental Handpiece” (K780038) by Lares Manufacturing Co.; and the “W-H Topair Dental Handpie…	Midwest	1986	—
*	K780038	Dental Handpiece Summary page 1 …Predicate Devices: “Fiber Optic High Speed Handpiece” (K760794) and “Tradition High Speed Handpiece” (K863677), both manufac- tured by Midwest; the “Dental Handpiece” (K780038) by Lares Manufacturing Co.; and the “W-H Topair Dental Handpiece” (K912786) by Sabra. Device Description: The Impact Air 45 Han…	Lares Manufacturing Co., Inc.	1978	—
*	K912786	W-H Topair Dental Handpiece Summary page 1 …tion High Speed Handpiece” (K863677), both manufac- tured by Midwest; the “Dental Handpiece” (K780038) by Lares Manufacturing Co.; and the “W-H Topair Dental Handpiece” (K912786) by Sabra. Device Description: The Impact Air 45 Handpiece for Endodontic Use is an air-powered dental handpiece intended for us…	Sabra-The Dental Products Group	1991	—

Also cleared against K760794: 1 other device →

What descends from it? (10)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K130455	430 SWL 45 and 430 SW 45 High-Speed Handpieces	Dentalez Group, Stardental Division	2013	9

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?

None of the 4 ancestors has a recall.
Of its descendants, K130455 (Dentalez Group, Stardental Division, 2013) has gone furthest, with 9 descendants of its own.
1 other device also cites its predicate K760794.

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.

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 Impact Air 45 Handpiece for Endodontic Use is an air-powered dental handpiece intended for use in apicoectomy (root canal drainage) and other endodontic procedures for which a conventional handpiece would be used.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K972375 · printed Nov 5, 2026

Cite this page

510(k) Report. “K972375: Impact Air 45 Handpiece for Endodontic Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972375

Report an extraction error

Are you the manufacturer?

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