510(k) · Cleared

Cleared

Tradition High Speed Handpiece

K863677510(k) TraditionalCleared Oct 6, 198617-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

Midwest · EFB Handpiece, Air-Powered, Dental

Cleared on Oct 6, 1986 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 37 later devices descend from it.

Decided: Oct 6, 1986
Review: 17 days
Class: Class I
Product code: EFB
Recalls: None
Predicates: 0

37 later devices descend from it, 5 citing it directly.

This deviceK863677 Tradition High Speed HandpieceMidwest · 1986
Descendant · cites it directly · 24 of its ownK965238 T1 Control High Speed Dental HandpieceSiemens AG · 1997
Descendant · 2 generations on · 23 of its ownK073478 Supertorque High-Speed Handpieces and Gentlepower Handpieces and…Sybron Dental Specialties, Inc. · 2008
Descendant · cites it directly · 18 of its ownK972376 Impact Air 45 Handpiece for Periodontal UseGlenwood, LLC · 1997
Descendant · 2 generations on · 17 of its ownK101717 Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam…Aerobine, Inc. · 2010
Descendant · 3 generations on · 16 of its ownK112024 TI-Max X450Nakanishi, Inc. · 2012

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

1997high 3 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 37 · See all

K965238T1 Control High Speed Dental HandpieceSiemens AG · 1997 · cites it directly24descendants
K073478Supertorque High-Speed Handpieces and Gentlepower Handpieces and AttachementsSybron Dental Specialties, Inc. · 2008 · 2 generations on23descendants
K972376Impact Air 45 Handpiece for Periodontal UseGlenwood, LLC · 1997 · cites it directly18descendants
K101717Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam 45; Dexor 45; Karam 4H…Aerobine, Inc. · 2010 · 2 generations on17descendants
K112024TI-Max X450Nakanishi, Inc. · 2012 · 3 generations on16descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K863677	Tradition High Speed Handpiece	Midwest	1986	—
+1	K965238	T1 Control High Speed Dental Handpiece	Siemens AG	1997	—
+2	K073478	Supertorque High-Speed Handpieces and Gentlepower Handpieces and Attachements	Sybron Dental Specialties, Inc.	2008	—
+1	K972376	Impact Air 45 Handpiece for Periodontal Use	Glenwood, LLC	1997	—
+2	K101717	Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam 45; Dexor…	Aerobine, Inc.	2010	—
+3	K112024	TI-Max X450	Nakanishi, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	3	0
2008	2	0
2009	1	0
2010	2	0
2011	1	0
2012	2	0
2013	2	0
2014	3	0
2015	3	0
2017	1	0
2018	2	0
2019	1	0
2020	2	0
2021	2	0
2022	2	0
2023	3	0
2024	2	0
2026	3	0

FIG. 1 — Lineage of K863677, 1986–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (37)

See all 37

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K965238	T1 Control High Speed Dental Handpiece	Siemens AG	1997	24
K972376	Impact Air 45 Handpiece for Periodontal Use	Glenwood, LLC	1997	18
K102517	Tiger 500 Series High Speed Handpieces and Attachments	Thunder Tiger Corp.	2011	13
K972375	Impact Air 45 Handpiece for Endodontic Use	Glenwood, LLC	1997	10
K073652	ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece, E-Type Straight…	Nakamura Magnifier Co., Ltd.	2008	3

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?

Of its descendants, K965238 (Siemens AG, 1997) has gone furthest, with 24 descendants of its own.

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	—

https://510kreport.com/device/K863677 · printed Nov 6, 2026

Cite this page

510(k) Report. “K863677: Tradition High Speed Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K863677

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026