510(k) · Cleared
ClearedRetraxil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kulzer, LLC · MVL Cord, Retraction
Cleared on Sep 24, 2025 as substantially equivalent to K050180 (Produits Dentaires Pierre Rolland, 2005) and 1 other predicate after a 279-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Sep 24, 2025
- Review
- 279 days
- Class
- Class U
- Product code
- MVL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K050180 (2005). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK050180 Expa-SylProduits Dentaires Pierre Rolland · 2005
- This deviceK243910 RetraxilKulzer, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050180 | Expa-Syl | Produits Dentaires Pierre Rolland | 2005 | — |
| 0 (this device) | K243910 | Retraxil | Kulzer, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MVL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MVL device
- #1 K254239 CyClean Cordscore 11.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
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.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 6 other devices also cite its predicate K050180.
How does its category compare?
All MVL devicesMVL Cord, Retraction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MVL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MVL
227in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MVL
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MVL
1in 2025
MAUDE reports naming product code MVL, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 91 | 0 | 1 |
| 2010 | 4 | 79 | 0 | 1 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 7 |
| 2013 | 2 | — | 0 | 5 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 4 | 227 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
For the temporary displacement of the marginal gingiva and drying of the gingival sulcus, e.g. for
* conventional or digital impressions,
* cementation of temporary and permanent restorations
* and the creation of Class II and V fillings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243910: Retraxil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243910
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026