510(k) · Cleared
ClearedRetract Gingival Retraction/Hemostatic Paste
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parkell, Inc. · MVL Cord, Retraction
Cleared on Apr 12, 2012 as substantially equivalent to K083695 (Premier Dental Products Co., 2009) and 2 other predicates after a 106-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Apr 12, 2012
- Review
- 106 days
- Class
- Class U
- Product code
- MVL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K050180 (2005). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK050180 Expa-SylProduits Dentaires Pierre Rolland · 2005
- This deviceK113839 Retract Gingival Retraction/Hemostatic PasteParkell, Inc. · 2012
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) | K113839 | Retract Gingival Retraction/Hemostatic Paste | Parkell, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 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? (3)
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 |
|---|---|---|---|
| * | K083695 | TraxodentSummary page 1…mon Name: Gingival Retraction/Hemostatic Paste Classification Name: None Classification Product Code: MVL Predicate Devices: TRAXODENT (K083695), EXPASYL (K050180), RAGEGEL (K093711 1) Device Description: RETRACT is a dental product ca… | 2009 |
| * | K050180 | Expa-SylSummary page 1…Gingival Retraction/Hemostatic Paste Classification Name: None Classification Product Code: MVL Predicate Devices: TRAXODENT (K083695), EXPASYL (K050180), RAGEGEL (K093711 1) Device Description: RETRACT is a dental product capable of controllin… | 2005 |
| * | K093711 | RacegelSummary page 1…ssification Name: None Classification Product Code: MVL Predicate Devices: TRAXODENT (K083695), EXPASYL (K050180), RAGEGEL (K093711 1) Device Description: RETRACT is a dental product capable of controlling gingival bleeding… | 2010 |
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 3 ancestors has a recall.
- 1 other device also cites its predicate K083695.
How does its category compare?
All MVL devicesMVL Cord, Retraction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
RETRACT is a paste containing aluminum chloride which is used for the temporary
retraction and hemostasis of the gingival margin during dental procedures such as dental
impressions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113839: Retract Gingival Retraction/Hemostatic Paste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113839
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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