510(k) · Cleared

Cleared

Avant High Speed Handpiece, Avant Fiber Optic High Speed Handpiece, Model #'S Avant HS 100 & Avant HS 200

K983168510(k) TraditionalCleared Nov 18, 199869-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

Ora Innovations, Inc. · EFB Handpiece, Air-Powered, Dental

Cleared on Nov 18, 1998 as substantially equivalent to K963050 (Midwest Dental Products Corp., 1996) after a 69-day review. Its family tree reaches back 1 generation to 1996.

Decided: Nov 18, 1998
Review: 69 days
Class: Class I
Product code: EFB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K963050 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK963050 Tradition P, Push Button HandpieceMidwest Dental Products Corp. · 1996 · Recalled
This deviceK983168 Avant High Speed Handpiece, Avant Fiber Optic High Speed Handpiece…Ora Innovations, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K963050	Tradition P, Push Button Handpiece	Midwest Dental Products Corp.	1996	3
0 (this device)	K983168	Avant High Speed Handpiece, Avant Fiber Optic High Speed Handpiece, Model #'S…	Ora Innovations, Inc.	1998	—

FIG. 1 — Lineage of K983168, 1996–1998Source: 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? (1)

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
*	K963050	Tradition P, Push Button Handpiece Summary page 1 …me: Dental handpiece and accessories, Class 1, 21 CFR 872.4200 Legally marketed device for substantial equivalence comparison: Midwest Tradition P High Speed Handpiece (K963050) Manufactured by Dentsply Midwest, Des Plaines, IL Description of the device: The Avant is a high speed dental handpiece, 132 mi…	Midwest Dental Products Corp.	1996	3

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?

Its one ancestor has a recall.

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 Avant handpiece will be used by dentists to remove decayed tooth structure,

and to cut or alter the shape of teeth so they may be restored to form and function.

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/K983168 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983168: Avant High Speed Handpiece, Avant Fiber Optic High Speed Handpiece, Model #'S Avant HS 100 & Avant HS 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983168

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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