510(k) · Cleared
ClearedEnamelite Acryseal Spray Sealant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enamelite, LLC · EBD Coating, Filling Material, Resin
Cleared on Dec 22, 2009 as substantially equivalent to K081981 (Lang Dental Mfg. Co., Inc., 2008) and 2 other predicates after an 84-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Dec 22, 2009
- Review
- 84 days
- Class
- Class II
- Product code
- EBD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K945604 (1995). 5 ancestors in all, the oldest K892452 (1989). 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 |
|---|---|---|---|---|---|
| −3 | K945604 | Ecliptomer | Bisco, Inc. | 1995 | — |
| −2 | K020570 | Simplicity | Apex Dental Materials, Inc. | 2002 | — |
| −1 | K061981 | Surpass | Apex Dental Materials, Inc. | 2006 | — |
| 0 (this device) | K093019 | Enamelite Acryseal Spray Sealant | Enamelite, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2008 | 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 EBD? 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 EBD device
- #1 K254091 Glossy Coat (15ML)score 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 |
|---|---|---|---|
| * | K081981 | Lang Dental Acrylic Primer | 2008 |
| * | K892452 | Palaseal (R)Summary page 2…valence: Enamelite Acryseal Acrylic Spray and Enamelite Acryseal-CB Spray are substantially equivalent to Lang Dental Acrylic Primer (KOS81981), Palaseal (K892452), and Apex Dental Surpass (K06198 1) . Each of the devices have similar technical features, indications for use, a… | 1989 |
| * | K061981 | SurpassSummary page 2…c Spray and Enamelite Acryseal-CB Spray are substantially equivalent to Lang Dental Acrylic Primer (KOS81981), Palaseal (K892452), and Apex Dental Surpass (K06198 1) . Each of the devices have similar technical features, indications for use, and the safety and effectiveness of t… | 2006 |
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 14 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All EBD devicesEBD Coating, Filling Material, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · EBD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBD
76in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBD
No recall names EBD since 2007.
Adverse event reports per year · EBD
5in 2023
MAUDE reports naming product code EBD, 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 | 0 |
| 2008 | 3 | 76 | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Enamelite Acryseal and Enamelite Acryseal-CB Spray Sealant is intended for use as a sealant/bonding agent intended to reline, repair, or rebase denture surfaces and CAD/CAM produced/milled acrylic and composite replacement dental restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093019 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093019: Enamelite Acryseal Spray Sealant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093019
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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