510(k) · Cleared

Cleared

Orl-E-92 Surgical Drill System

K984244510(k) TraditionalCleared Feb 23, 199988-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

Bien Air USA, Inc. · EFB Handpiece, Air-Powered, Dental

Cleared on Feb 23, 1999 as substantially equivalent to K934783 (Kavo America, 1994) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1979. 1 later device descends from it.

Decided: Feb 23, 1999
Review: 88 days
Class: Class I
Product code: EFB
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K792159 (1979). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK792159 Fisch Drill SystemJedmed Instrument Co. · 1979 · Recalled
This deviceK984244 Orl-E-92 Surgical Drill SystemBien Air USA, Inc. · 1999
Descendant · cites it directly · 0 of its ownK031540 Apex Electric Handpiece SystemLares Research, Inc. · 2003

Most influential descendants

Showing 1 of 1 · See all

K031540Apex Electric Handpiece SystemLares Research, Inc. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K792159	Fisch Drill System	Jedmed Instrument Co.	1979	1
0 (this device)	K984244	Orl-E-92 Surgical Drill System	Bien Air USA, Inc.	1999	—
+1	K031540	Apex Electric Handpiece System	Lares Research, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K984244, 1979–2003Source: 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? (2)

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
*	K934783	Kavo Intrasept 905 Summary page 1 …ication Name: Dental Handpieces and Accessories 21 CFR 872.4200 IDENTIFICATION OF PREDICATE DEVICES Company Device 510(k) No. Date Cleared KaVo America Intrasept 905 K934783 05/16/94 Jedmed Fisch Drill System K792159 11/27/79 CONFIDENTIAL Bien-Air ORL-E-92 Surgical Drill System Origina…	Kavo America	1994	—
*	K792159	Fisch Drill System Summary page 1 …ries 21 CFR 872.4200 IDENTIFICATION OF PREDICATE DEVICES Company Device 510(k) No. Date Cleared KaVo America Intrasept 905 K934783 05/16/94 Jedmed Fisch Drill System K792159 11/27/79 CONFIDENTIAL Bien-Air ORL-E-92 Surgical Drill System Original Premarket 510(k) Notification 13.4 13.5…	Jedmed Instrument Co.	1979	1

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K031540	Apex Electric Handpiece System	Lares Research, Inc.	2003	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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K031540 (Lares Research, Inc., 2003) has gone furthest, with 0 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?

The Bien-Air ORL-E-92 Surgical Drill System is indicated for the preparation of intraoral bone for microsurgery and implantology and for apicoectomies.

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/K984244 · printed Nov 6, 2026

Cite this page

510(k) Report. “K984244: Orl-E-92 Surgical Drill System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984244

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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