510(k) · Cleared
ClearedEmbrace Wetbond Clear Sealant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulpdent Corporation · EBC Sealant, Pit And Fissure, And Conditioner
Cleared on Feb 8, 2006 after a 170-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Feb 8, 2006
- Review
- 170 days
- Class
- Class II
- Product code
- EBC
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK052281 Embrace Wetbond Clear SealantPulpdent Corporation · 2006
- Descendant · cites it directly · 3 of its ownK073395 Gilb-2, Glass Ionomer Protective Coating3M Espe Dental Products · 2008
- Descendant · 2 generations on · 2 of its ownK091632 SPK Sealant3M Company · 2009
- Descendant · cites it directly · 1 of its ownK112517 Ultraseal XT HydroUltradent Products, Inc. · 2011
- Descendant · 3 generations on · 1 of its ownK100062 Infiltration KitDmg USA, Inc. · 2010
- Descendant · 4 generations on · 0 of its ownK251124 G-Bond UniversalGC America, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K073395Gilb-2, Glass Ionomer Protective Coating3M Espe Dental Products · 2008 · cites it directly3descendants
- K091632SPK Sealant3M Company · 2009 · 2 generations on2descendants
- K112517Ultraseal XT HydroUltradent Products, Inc. · 2011 · cites it directly1descendant
- K100062Infiltration KitDmg USA, Inc. · 2010 · 3 generations on1descendant
- K251124G-Bond UniversalGC America, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052281 | Embrace Wetbond Clear Sealant | Pulpdent Corporation | 2006 | — |
| +1 | K073395 | Gilb-2, Glass Ionomer Protective Coating | 3M Espe Dental Products | 2008 | — |
| +2 | K091632 | SPK Sealant | 3M Company | 2009 | — |
| +1 | K112517 | Ultraseal XT Hydro | Ultradent Products, Inc. | 2011 | — |
| +3 | K100062 | Infiltration Kit | Dmg USA, Inc. | 2010 | — |
| +4 | K251124 | G-Bond Universal | GC America, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 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? (5)
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 |
|---|---|---|---|
| * | — | Pulpdent Embrace Pit and Fissure Sealant Named without a submission number | |
| * | — | Pulpdent Embrace Seal-n-Shine Named without a submission number | |
| * | — | Dentsply Delton Clear Named without a submission number | |
| * | — | Bisco BisCover Named without a submission number | |
| * | — | Cosmedent CosmeSeal Named without a submission number |
What descends from it? (7)
3 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, K073395 (3M Espe Dental Products, 2008) has gone furthest, with 3 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?
EmbraceTM WetBond TM Clear Sealant is a hydrophilic, light-cured material recommended for use as a pit and fissure sealant. EmbraceTM WetBondTM Clear Sealant may be used to seal small defects such as buccal pits, lingual grooves or facial surface defects. EmbraceTM WetBondTM Clear Sealant may also be used as an orthodontic bracket coating. EmbraceTM WetBondTM Clear Sealant hardens/cures such that the material is clear.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052281: Embrace Wetbond Clear Sealant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052281
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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