510(k) · Cleared
ClearedGrandio Seal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Voco GmbH · EBC Sealant, Pit And Fissure, And Conditioner
Cleared on Oct 2, 2006 after a 52-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Oct 2, 2006
- Review
- 52 days
- Class
- Class II
- Product code
- EBC
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK062344 Grandio SealVoco GmbH · 2006
- Descendant · cites it directly · 2 of its ownK091632 SPK Sealant3M Company · 2009
- Descendant · 2 generations on · 1 of its ownK100062 Infiltration KitDmg USA, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK251124 G-Bond UniversalGC America, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK081493 Infiltration KitDmg USA, Inc. · 2008
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062344 | Grandio Seal | Voco GmbH | 2006 | — |
| +1 | K091632 | SPK Sealant | 3M Company | 2009 | — |
| +2 | K100062 | Infiltration Kit | Dmg USA, Inc. | 2010 | — |
| +3 | K251124 | G-Bond Universal | GC America, Inc. | 2025 | — |
| +1 | K081493 | Infiltration Kit | Dmg USA, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2025 | 1 | 0 |
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 EBC? 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 EBC device
- #1 K243254 Parkell Pit and Fissure Sealantscore 12.8 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (4)
2 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, K091632 (3M Company, 2009) has gone furthest, with 2 descendants of its own.
How does its category compare?
All EBC devicesEBC Sealant, Pit And Fissure, And Conditioner: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBC
80in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBC
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBC
6in 2025
MAUDE reports naming product code EBC, 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 | 3 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 5 | 115 | 0 | 0 |
| 2011 | 3 | 80 | 0 | 5 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 11 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 1 | 0 |
| 2016 | 1 | — | 2 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 6 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Grandio Seal is intended for sealing/filling of pits and fissures, sealing/facing enamel surfaces, covering of caries predilection sites during orthodontic treatment, sealing of damaged composite or cement fillings (protective layer against moisture) and sealing of deciduous teeth.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K062344 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062344: Grandio Seal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062344
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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