510(k) Report

FDA product code · Dental

Crown And Bridge, Long-Term Temporary, Resin

POWClass II21 CFR 872.3770510(k) required2 decisions since 20230 recalls

2 FDA decisions since 2023. 510(k) reviews decided 2021–2025 took a median of 60 days (half between 60 and 60). No recall names this code.

For the fabrication of long-term temporary crowns and bridges

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 POW 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 · POW

1in 2023

2023: 12026 (partial year): 1
2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · POW

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

Recalls per year · POW

No recall names POW since 2007.

Adverse event reports per year · POW

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—01
20231—00
20240—00
20250—00
20261—0—
FIG. 1 — POW by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in POW? 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 872.3770.