FDA product code · Dental
Clamp, Rubber Dam
FDA lists EEF as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 872.9 applies, such as a new intended use or a different fundamental technology. 3 FDA decisions since 1978. No recall names this code.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of EEF 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 · EEF
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · EEF
Too few EEF 510(k)s in any year since 2007 to give a median.
Recalls per year · EEF
No recall names EEF since 2007.
Adverse event reports per year · EEF
7in 2022
MAUDE reports naming product code EEF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 37 |
| 2013 | 0 | — | 0 | 23 |
| 2014 | 0 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in EEF? 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) ReportRelated product codes
Other codes under 21 CFR 872.6300.