510(k) · Cleared

Cleared

W & H Assistina

K010127510(k) TraditionalCleared Oct 5, 2001275-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 Oct 5, 2001 after a 275-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.

Decided: Oct 5, 2001
Review: 275 days
Class: Class I
Product code: EFB
Recalls: None
Predicates: 0

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

This deviceK010127 W & H AssistinaA-Dec, Inc. · 2001
Descendant · cites it directly · 3 of its ownK070074 Lubrina, Model Him-1J. Morita USA, Inc. · 2007
Descendant · cites it directly · 1 of its ownK070297 Clearview Dental Handpiece Lubricator and LubricantDental Air Solutions of Nc, Inc. · 2007
Descendant · 2 generations on · 0 of its ownK190509 Lubrina 2J. Morita USA, Inc. · 2020
Descendant · 2 generations on · 0 of its ownK103697 TorqtechJ. Morita USA, Inc. · 2012
Descendant · cites it directly · 0 of its ownK093072 Starcare Handpiece Maintenance UnitDentalez, Inc. · 2009

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2007high 3 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 6 · See all

K070074Lubrina, Model Him-1J. Morita USA, Inc. · 2007 · cites it directly3descendants
K070297Clearview Dental Handpiece Lubricator and LubricantDental Air Solutions of Nc, Inc. · 2007 · cites it directly1descendant
K190509Lubrina 2J. Morita USA, Inc. · 2020 · 2 generations on0descendants
K103697TorqtechJ. Morita USA, Inc. · 2012 · 2 generations on0descendants
K093072Starcare Handpiece Maintenance UnitDentalez, Inc. · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010127	W & H Assistina	A-Dec, Inc.	2001	—
+1	K070074	Lubrina, Model Him-1	J. Morita USA, Inc.	2007	—
+1	K070297	Clearview Dental Handpiece Lubricator and Lubricant	Dental Air Solutions of Nc, Inc.	2007	—
+2	K190509	Lubrina 2	J. Morita USA, Inc.	2020	—
+2	K103697	Torqtech	J. Morita USA, Inc.	2012	—
+1	K093072	Starcare Handpiece Maintenance Unit	Dentalez, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	3	0
2009	1	0
2012	1	0
2020	1	0

FIG. 1 — Lineage of K010127, 2001–2020Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K070074	Lubrina, Model Him-1	J. Morita USA, Inc.	2007	3
K070297	Clearview Dental Handpiece Lubricator and Lubricant	Dental Air Solutions of Nc, Inc.	2007	1
K093072	Starcare Handpiece Maintenance Unit	Dentalez, Inc.	2009	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, K070074 (J. Morita USA, Inc., 2007) has gone furthest, with 3 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/K010127 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010127: W & H Assistina.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010127

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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