510(k) · Cleared

Cleared

Dentiseptic HPC

K031851510(k) TraditionalCleared Aug 1, 200346-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

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

Cleared on Aug 1, 2003 as substantially equivalent to K963664 (Filmtech, Inc., 1996) and 1 other predicate after a 46-day review. Its family tree reaches back 2 generations to 1990.

Decided: Aug 1, 2003
Review: 46 days
Class: Class I
Product code: EFB
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K900093 (1990). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK900093 Disposa-Shield (TM) Infection Control BarrierDentsply Intl. · 1990
1 generation backK963664 Dental Handpiece and AccessoryFilmtech, Inc. · 1996
This deviceK031851 Dentiseptic HPCBethel, Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K900093	Disposa-Shield (TM) Infection Control Barrier	Dentsply Intl.	1990	—
−1	K963664	Dental Handpiece and Accessory	Filmtech, Inc.	1996	—
0 (this device)	K031851	Dentiseptic HPC	Bethel, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

FIG. 1 — Lineage of K031851, 1990–2003Source: 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
*	K963664	Dental Handpiece and Accessory Summary page 2 …K. Predicate Devices Filmtech, Inc.’s Brixton Infection Controi Barrier 5 1O(k) Document - Control Number -- K963664 Dentsply International, Inc.’s Disposa-Shield Infection ControI Barrier 5 1O(k) Document Control Number -- K9000…	Filmtech, Inc.	1996	—
*	K900093	Disposa-Shield (TM) Infection Control Barrier Summary page 2 …Control Number -- K963664 Dentsply International, Inc.’s Disposa-Shield Infection ControI Barrier 5 1O(k) Document Control Number -- K900093 11 Dentaseptic HPC 5 10(K) Notification <# .*‘-…	Dentsply Intl.	1990	—

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 13 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
None of the 3 ancestors 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 Dentaseptic HPC device is intended as a single use, disposable, transparent, plastic, disposable, non-sterile protective cover to be placed over various high speed and low speed dental handpieces used in the dental/ clinical setting. The cover acts as a physical barrier that assists in providing surface protection for the handpieces, reducing cross contamination of equipment, augmenting existing infection control techniques and making clean up and disinfection less time consuming.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031851 · printed Nov 4, 2026

Cite this page

510(k) Report. “K031851: Dentiseptic HPC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031851

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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