510(k) · Cleared
ClearedExpa-Syl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Produits Dentaires Pierre Rolland · MVL Cord, Retraction
Cleared on Feb 11, 2005 after a 16-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Feb 11, 2005
- Review
- 16 days
- Class
- Class U
- Product code
- MVL
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 7 citing it directly.
- This deviceK050180 Expa-SylProduits Dentaires Pierre Rolland · 2005
- Descendant · cites it directly · 2 of its ownK082116 Hemostasyl PasteSatelec · 2008
- Descendant · cites it directly · 1 of its ownK162662 GingiDent Gingival Retraction PastePac-Dent International, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK253797 One-StopMediclus Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK243910 RetraxilKulzer, LLC · 2025
- Descendant · cites it directly · 0 of its ownK130580 Retraction PasteDmg USA, Inc. · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K082116Hemostasyl PasteSatelec · 2008 · cites it directly2descendants
- K162662GingiDent Gingival Retraction PastePac-Dent International, Inc. · 2017 · cites it directly1descendant
- K253797One-StopMediclus Co., Ltd. · 2026 · 2 generations on0descendants
- K243910RetraxilKulzer, LLC · 2025 · cites it directly0descendants
- K130580Retraction PasteDmg USA, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050180 | Expa-Syl | Produits Dentaires Pierre Rolland | 2005 | — |
| +1 | K082116 | Hemostasyl Paste | Satelec | 2008 | — |
| +1 | K162662 | GingiDent Gingival Retraction Paste | Pac-Dent International, Inc. | 2017 | — |
| +2 | K253797 | One-Stop | Mediclus Co., Ltd. | 2026 | — |
| +1 | K243910 | Retraxil | Kulzer, LLC | 2025 | — |
| +1 | K130580 | Retraction Paste | Dmg USA, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Stay-put Impregnated Named without a submission number | |
| * | — | Ultrapak E Named without a submission number |
What descends from it? (8)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K082116 (Satelec, 2008) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MVL devicesMVL Cord, Retraction: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Expa-syl is a paste containing aluminum chloride which is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050180 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050180: Expa-Syl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050180
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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