510(k) · Cleared

Cleared

Rapidd Highspeed Dental Handpiece

K003518510(k) TraditionalCleared Jan 9, 200155-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

Dentsply Intl. · EFB Handpiece, Air-Powered, Dental

Cleared on Jan 9, 2001 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it.

Decided: Jan 9, 2001
Review: 55 days
Class: Class I
Product code: EFB
Recalls: None
Predicates: 0

24 later devices descend from it, 3 citing it directly.

This deviceK003518 Rapidd Highspeed Dental HandpieceDentsply Intl. · 2001
Descendant · cites it directly · 13 of its ownK102517 Tiger 500 Series High Speed Handpieces and AttachmentsThunder Tiger Corp. · 2011
Descendant · 2 generations on · 8 of its ownK152146 High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015
Descendant · cites it directly · 8 of its ownK072989 Axis SystemDentsply Intl., Inc. · 2008
Descendant · 2 generations on · 7 of its ownK143704 Advanced Air SystemW&H Dentalwerk Buermoos GmbH · 2015
Descendant · 3 generations on · 6 of its ownK162926 Air-Powered Handpieces and Handpiece AttachmentsW&H Dentalwerk Burmoos GmbH · 2017

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2004high 6 (2024) · low 0 (2005)2026

Most influential descendants

Showing 5 of 24 · See all

K102517Tiger 500 Series High Speed Handpieces and AttachmentsThunder Tiger Corp. · 2011 · cites it directly13descendants
K152146High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015 · 2 generations on8descendants
K072989Axis SystemDentsply Intl., Inc. · 2008 · cites it directly8descendants
K143704Advanced Air SystemW&H Dentalwerk Buermoos GmbH · 2015 · 2 generations on7descendants
K162926Air-Powered Handpieces and Handpiece AttachmentsW&H Dentalwerk Burmoos GmbH · 2017 · 3 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003518	Rapidd Highspeed Dental Handpiece	Dentsply Intl.	2001	—
+1	K102517	Tiger 500 Series High Speed Handpieces and Attachments	Thunder Tiger Corp.	2011	—
+2	K152146	High Speed Handpieces and Accessories	Codent Technical Industry Co., Ltd.	2015	—
+1	K072989	Axis System	Dentsply Intl., Inc.	2008	—
+2	K143704	Advanced Air System	W&H Dentalwerk Buermoos GmbH	2015	—
+3	K162926	Air-Powered Handpieces and Handpiece Attachments	W&H Dentalwerk Burmoos GmbH	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2008	1	0
2011	1	0
2012	1	0
2014	1	0
2015	2	0
2017	2	0
2018	1	0
2019	1	0
2020	2	0
2022	2	0
2023	2	0
2024	6	0
2026	1	0

FIG. 1 — Lineage of K003518, 2001–2026Source: 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? (24)

See all 24

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

Number	Device	Applicant	Decided	Descendants
K102517	Tiger 500 Series High Speed Handpieces and Attachments	Thunder Tiger Corp.	2011	13
K072989	Axis System	Dentsply Intl., Inc.	2008	8
K041755	Cromax High Speed Turbine Handpiece	J.R. Medical Technologies, Inc.	2004	0

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, K102517 (Thunder Tiger Corp., 2011) has gone furthest, with 13 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/K003518 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003518: Rapidd Highspeed Dental Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003518

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Record history

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