510(k) · Cleared

Cleared

Synea-HS High Speed-Handpiece

K992011510(k) TraditionalCleared Sep 10, 199987-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

A-Dec, Inc. · EFB Handpiece, Air-Powered, Dental

Cleared on Sep 10, 1999 after an 87-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.

Decided: Sep 10, 1999
Review: 87 days
Class: Class I
Product code: EFB
Recalls: None
Predicates: 0

12 later devices descend from it, 1 citing it directly.

This deviceK992011 Synea-HS High Speed-HandpieceA-Dec, Inc. · 1999
Descendant · cites it directly · 11 of its ownK043498 Twin Power Turbine High Speed Air Turbine Dental HandpieceJ. Morita USA, Inc. · 2005
Descendant · 2 generations on · 7 of its ownK061701 High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power…J. Morita USA, Inc. · 2006
Descendant · 3 generations on · 5 of its ownK130560 Mastertorque Lux 8900 LKaltenbach & Voigt GmbH · 2013
Descendant · 4 generations on · 3 of its ownK141886 MDK HandpiecesModern Korea Co., Ltd. · 2015
Descendant · 2 generations on · 2 of its ownK131319 T1/T2/T3 Turbine FamilySirona Dental Systems GmbH · 2014

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2005high 2 (2026) · low 0 (2007)2026

Most influential descendants

Showing 5 of 12 · See all

K043498Twin Power Turbine High Speed Air Turbine Dental HandpieceJ. Morita USA, Inc. · 2005 · cites it directly11descendants
K061701High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power Turbine 4H)J. Morita USA, Inc. · 2006 · 2 generations on7descendants
K130560Mastertorque Lux 8900 LKaltenbach & Voigt GmbH · 2013 · 3 generations on5descendants
K141886MDK HandpiecesModern Korea Co., Ltd. · 2015 · 4 generations on3descendants
K131319T1/T2/T3 Turbine FamilySirona Dental Systems GmbH · 2014 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K992011	Synea-HS High Speed-Handpiece	A-Dec, Inc.	1999	—
+1	K043498	Twin Power Turbine High Speed Air Turbine Dental Handpiece	J. Morita USA, Inc.	2005	—
+2	K061701	High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power Turbine 4H)	J. Morita USA, Inc.	2006	—
+3	K130560	Mastertorque Lux 8900 L	Kaltenbach & Voigt GmbH	2013	—
+4	K141886	MDK Handpieces	Modern Korea Co., Ltd.	2015	—
+2	K131319	T1/T2/T3 Turbine Family	Sirona Dental Systems GmbH	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2012	1	0
2013	1	0
2014	1	0
2015	1	0
2018	1	0
2021	1	0
2022	1	0
2023	1	0
2026	2	0

FIG. 1 — Lineage of K992011, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K043498	Twin Power Turbine High Speed Air Turbine Dental Handpiece	J. Morita USA, Inc.	2005	11

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, K043498 (J. Morita USA, Inc., 2005) has gone furthest, with 11 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	—

What is it indicated for?

A dental high-speed handpiece is designed for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K992011 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992011: Synea-HS High Speed-Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992011

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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