510(k) · Cleared

Cleared

Starcare Handpiece Maintenance Unit

K093072510(k) TraditionalCleared Dec 28, 200989-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

Dentalez, Inc. · EFB Handpiece, Air-Powered, Dental

Cleared on Dec 28, 2009 as substantially equivalent to K073319 (Scican, Ltd., 2008) and 2 other predicates after an 89-day review. Its family tree reaches back 2 generations to 2001.

Decided: Dec 28, 2009
Review: 89 days
Class: Class I
Product code: EFB
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K010127 (2001). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK010127 W & H AssistinaA-Dec, Inc. · 2001
1 generation backK070074 Lubrina, Model Him-1J. Morita USA, Inc. · 2007
This deviceK093072 Starcare Handpiece Maintenance UnitDentalez, Inc. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K010127	W & H Assistina	A-Dec, Inc.	2001	—
−1	K070074	Lubrina, Model Him-1	J. Morita USA, Inc.	2007	—
0 (this device)	K093072	Starcare Handpiece Maintenance Unit	Dentalez, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2008	1	0

FIG. 1 — Lineage of K093072, 2001–2009Source: 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 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

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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
*	K073319	Statmatic 31 Handpiece Maintenance Unit Summary page 1 …ation: DEC 2 8 20p9 Handpiece; Air-powered, Dental (21 C.F.R. § 872.4200, Product code EFB) Predicate Device: Statmatic, manufactured by SciCan LTD. Ontario, Canada (K073319) Lubrina, manufactured by J. Morita USA, Inc., Irvine, CA. (K070074) Assistina, manufactured by A-Dec Incorporated, Newburg, OR (…	Scican, Ltd.	2008	—
*	K070074	Lubrina, Model Him-1 Summary page 1 …2.4200, Product code EFB) Predicate Device: Statmatic, manufactured by SciCan LTD. Ontario, Canada (K073319) Lubrina, manufactured by J. Morita USA, Inc., Irvine, CA. (K070074) Assistina, manufactured by A-Dec Incorporated, Newburg, OR (K010127) StarCare Handpiece Maintenance Unit has similar intended u…	J. Morita USA, Inc.	2007	—
*	K010127	W & H Assistina Summary page 1 …by SciCan LTD. Ontario, Canada (K073319) Lubrina, manufactured by J. Morita USA, Inc., Irvine, CA. (K070074) Assistina, manufactured by A-Dec Incorporated, Newburg, OR (K010127) StarCare Handpiece Maintenance Unit has similar intended uses, similar methods of operation and similar technology to the previ…	A-Dec, Inc.	2001	—

Also cleared against K073319: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
1 of the 4 ancestors has a recall of any class.
1 other device also cites its predicate K073319.

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. 2009, this device’s year, is highlighted.

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?

The StarCare Handpiece Maintenance Unit is intended for the internal cleaning, i.e purging of old lubricant, and the lubrication of air-driven high speed handpieces, electric micromotor attachments and turbines used in dentistry.

StarCare Handpiece Maintenance Unit should be used only after the handpieces have been externally cleaned and prior to sterilization.

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/K093072 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093072: Starcare Handpiece Maintenance Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093072

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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