FDA product code · Dental

Oral Surgery Tray

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

PWLClass I21 CFR 872.45650 decisions15 recalls

0 FDA decisions. 15 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 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.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…

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 PWL 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 · PWL

FDA has decided no PWL device since 2007.

Median 510(k) review, days · PWL

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

Recalls per year · PWL

15in 2022

2007high 15 (2022) · low 0 (2007)2026

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

Adverse event reports per year · PWL

No MAUDE report names PWL since 2007.

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	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	15	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

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

Planning a device in PWL? 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

Related product codes

Other codes under 21 CFR 872.4565.

NYC Dental Prophylaxis Kit EKA File, Margin Finishing, Operative EKB Explorer, Operative EMG Forceps, Tooth Extractor, Surgical EKJ Burnisher, Operative ELA Instrument, Hand, Calculus Removal EIY Instrument, Filling, Plastic, Dental ECS Pusher, Band, Orthodontic EML Chisel, Bone, Surgical NYG Lapping Tool Kit EKP Reamer, Pulp Canal, Endodontic DZN Instruments, Dental Hand

Oral Surgery Tray

What has been recalled in PWL lately?

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