FDA product code · Dental

General Purpose Dental Tray

Name: FDA decisions, review times, recalls and adverse event reports for product code OFX
Creator: 510(k) Report

OFXClass I21 CFR 872.66400 decisions11 recalls

0 FDA decisions. 11 recalls name this code, 0 of them Class I.

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, dental panel

Twenty years of OFX at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · OFX

FDA has decided no OFX device since 2007.

Median 510(k) review, days · OFX

Too few OFX 510(k)s in any year since 2007 to give a median.

Recalls per year · OFX

4so far in 2026, the most since 2007

2007high 4 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OFX

1in 2025

2007high 32 (2024) · low 0 (2007)2025

MAUDE reports naming product code OFX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	1	1
2020	—	0	0
2021	—	0	0
2022	—	3	0
2023	—	0	1
2024	—	3	32
2025	—	0	1
2026	—	4	—

FIG. 1 — OFX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OFX? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

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Other codes under 21 CFR 872.6640.

NRD Unit, Operative Dental, Accessories EIA Unit, Operative Dental DYN Mouthpiece, Saliva Ejector QYJ Dental Waterline Treatment Cartridge SJH Portable Dental Operative Unit EHZ Evacuator, Oral Cavity EBR Unit, Suction Operatory

General Purpose Dental Tray

What has been recalled in OFX lately?

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