510(k) · Cleared
ClearedSulcus Blue
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 Oct 13, 2011 as substantially equivalent to K082116 (Satelec, 2008) and 2 other predicates after a 93-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Oct 13, 2011
- Review
- 93 days
- Class
- Class U
- Product code
- MVL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K050180 (2005). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K050180 | Expa-Syl | Produits Dentaires Pierre Rolland | 2005 | — |
| −1 | K082116 | Hemostasyl Paste | Satelec | 2008 | — |
| 0 (this device) | K111978 | Sulcus Blue | Produits Dentaires Pierre Rolland | 2011 | — |
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? (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 |
|---|---|---|---|
| * | K082116 | Hemostasyl PasteSummary page 1…classified Product code: MVL 3. Devices for which Substantial Equivalence is claimed: - HEMOSTASYL (PRODUITS DENTAIRES PIERRE ROLLAND) K0821 16 dated 12/17/2008 - EXPASYL (PRODUITS DENTAIRES PIERRE ROLLAND) K050180 dated 02/11/2005 - TRAXODENT (PREMIER DENTAL… | 2008 |
| * | K050180 | Expa-SylSummary page 1…stantial Equivalence is claimed: - HEMOSTASYL (PRODUITS DENTAIRES PIERRE ROLLAND) K0821 16 dated 12/17/2008 - EXPASYL (PRODUITS DENTAIRES PIERRE ROLLAND) K050180 dated 02/11/2005 - TRAXODENT (PREMIER DENTAL PRODUCTS CO) K083695 4. Device description SULCUSBLUE is a paste containing… | 2005 |
| * | K083695 | TraxodentSummary page 1…S PIERRE ROLLAND) K0821 16 dated 12/17/2008 - EXPASYL (PRODUITS DENTAIRES PIERRE ROLLAND) K050180 dated 02/11/2005 - TRAXODENT (PREMIER DENTAL PRODUCTS CO) K083695 4. Device description SULCUSBLUE is a paste containing aluminium chloride which is used, in association with compression caps (… | 2009 |
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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K082116.
How does its category compare?
All MVL devicesMVL Cord, Retraction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
SULCUSBLUE is a paste containing aluminium chloride which is intended to be used, in association with compression caps, 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/K111978 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111978: Sulcus Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111978
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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