510(k) · Cleared
ClearedMeisinger Benex, Model BE001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hager& Meisinger GmbH · EMG Forceps, Tooth Extractor, Surgical
Cleared on Apr 16, 2007 after a 264-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 16, 2007
- Review
- 264 days
- Class
- Class I
- Product code
- EMG
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EMG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All EMG devicesEMG Forceps, Tooth Extractor, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · EMG
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · EMG
Too few EMG 510(k)s in any year since 2007 to give a median.
Recalls per year · EMG
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EMG
1in 2019
MAUDE reports naming product code EMG, 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 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Meisinger Benex Tooth Extraction device is to be used to extract teeth and tooth roots when traditional forceps extraction is not possible or when tooth luxation trauma to the alveolar bone is to be kept to a minimum.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K062130 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062130: Meisinger Benex, Model BE001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062130
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026