510(k) · Cleared

Cleared

T1 Control High Speed Dental Handpiece

K965238510(k) TraditionalCleared Mar 19, 199778-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

Siemens AG · EFA Handpiece, Belt And/Or Gear Driven, Dental

Cleared on Mar 19, 1997 as substantially equivalent to K863677 (Midwest, 1986) and 2 other predicates after a 78-day review. Its family tree reaches back 1 generation to 1986. 24 later devices descend from it.

Decided: Mar 19, 1997
Review: 78 days
Class: Class I
Product code: EFA
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K863677 (1986). 3 ancestors in all. 24 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK863677 Tradition High Speed HandpieceMidwest · 1986
This deviceK965238 T1 Control High Speed Dental HandpieceSiemens AG · 1997
Descendant · cites it directly · 23 of its ownK073478 Supertorque High-Speed Handpieces and Gentlepower Handpieces and…Sybron Dental Specialties, Inc. · 2008
Descendant · 2 generations on · 13 of its ownK102517 Tiger 500 Series High Speed Handpieces and AttachmentsThunder Tiger Corp. · 2011
Descendant · 3 generations on · 8 of its ownK152146 High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015
Descendant · 2 generations on · 5 of its ownK130560 Mastertorque Lux 8900 LKaltenbach & Voigt GmbH · 2013
Descendant · 4 generations on · 4 of its ownK170229 Dental High-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2008high 3 (2026) · low 0 (2009)2026

Most influential descendants

Showing 5 of 24 · See all

K073478Supertorque High-Speed Handpieces and Gentlepower Handpieces and AttachementsSybron Dental Specialties, Inc. · 2008 · cites it directly23descendants
K102517Tiger 500 Series High Speed Handpieces and AttachmentsThunder Tiger Corp. · 2011 · 2 generations on13descendants
K152146High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015 · 3 generations on8descendants
K130560Mastertorque Lux 8900 LKaltenbach & Voigt GmbH · 2013 · 2 generations on5descendants
K170229Dental High-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017 · 4 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K863677	Tradition High Speed Handpiece	Midwest	1986	—
0 (this device)	K965238	T1 Control High Speed Dental Handpiece	Siemens AG	1997	—
+1	K073478	Supertorque High-Speed Handpieces and Gentlepower Handpieces and Attachements	Sybron Dental Specialties, Inc.	2008	—
+2	K102517	Tiger 500 Series High Speed Handpieces and Attachments	Thunder Tiger Corp.	2011	—
+3	K152146	High Speed Handpieces and Accessories	Codent Technical Industry Co., Ltd.	2015	—
+2	K130560	Mastertorque Lux 8900 L	Kaltenbach & Voigt GmbH	2013	—
+4	K170229	Dental High-speed Turbine Handpiece	Guangdong Jinme Medical Technology Co., Ltd.	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	1	0

Descendants by year cleared

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

FIG. 1 — Lineage of K965238, 1986–2026Source: 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 EFA? 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 EFA device

#1 K192809 Dental Handpiecescore 3.5 · 3 generations · no Class I recall

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What was it cleared against? (3)

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
*	K863677	Tradition High Speed Handpiece Summary page 2 …al handpieces currently in U.S. commercial distribution. Examples of substantially equivalent devices include the Tradition high-speed bandpiece manufactured by Midwest (K863677), the Star Dental 430 series high-speed handpiece manufactured by DEN-TAL-EZ, Inc. (K960719), and the W&H 898 Top Light high-spee…	Midwest	1986	—
*	K960719	Star Dental 430 Series High Speed Handpiece Summary page 2 …t devices include the Tradition high-speed bandpiece manufactured by Midwest (K863677), the Star Dental 430 series high-speed handpiece manufactured by DEN-TAL-EZ, Inc. (K960719), and the W&H 898 Top Light high-speed handpiece manufactured by A-DEC, Inc. (K944710). 7. PERFORMANCE TESTING The Siemens T1 C…	Dentalez Group	1996	1
*	K944710	W&H 898 Top Light Highspeed Summary page 2 …, the Star Dental 430 series high-speed handpiece manufactured by DEN-TAL-EZ, Inc. (K960719), and the W&H 898 Top Light high-speed handpiece manufactured by A-DEC, Inc. (K944710). 7. PERFORMANCE TESTING The Siemens T1 CONTROL Dental Handpiece complies with ISO Standard 7785-1 for High Speed Air Turbine H…	A-Dec, Inc.	1995	—

Also cleared against K863677: 4 other devices →

What descends from it? (24)

See all 24

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

Number	Device	Applicant	Decided	Descendants
K073478	Supertorque High-Speed Handpieces and Gentlepower Handpieces and Attachements	Sybron Dental Specialties, Inc.	2008	23

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?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K073478 (Sybron Dental Specialties, Inc., 2008) has gone furthest, with 23 descendants of its own.
4 other devices also cite its predicate K863677.

How does its category compare?

All EFA devices

EFA Handpiece, Belt And/Or Gear Driven, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EFA

1in 2020

2007high 4 (2009) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EFA

78in 2009

2007high 78 (2009)2026

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

Recalls per year · EFA

1in 2010

2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EFA

4in 2025

2007high 97 (2018) · low 0 (2009)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	1
2008	0	—	0	17
2009	4	78	0	0
2010	2	—	1	1
2011	0	—	0	4
2012	0	—	0	1
2013	0	—	0	0
2014	0	—	0	0
2015	1	—	0	0
2016	0	—	0	1
2017	1	—	0	2
2018	0	—	0	97
2019	0	—	0	59
2020	1	—	0	2
2021	0	—	0	0
2022	0	—	0	4
2023	0	—	0	3
2024	0	—	0	5
2025	0	—	0	4
2026	0	—	0	—

What is it indicated for?

The Siemens T1 CONTROL high speed dental handpiece is intended for use in the dental operatory to prepare dental cavities for restorations, such as fillings.

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/K965238 · printed Nov 5, 2026

Cite this page

510(k) Report. “K965238: T1 Control High Speed Dental Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K965238

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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