510(k) · Cleared
ClearedDurafinish All-Cure, Model S296
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parkell, Inc. · EBD Coating, Filling Material, Resin
Cleared on May 13, 2008 as substantially equivalent to K040599 (Parkell, Inc., 2004) after a 76-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- May 13, 2008
- Review
- 76 days
- Class
- Class II
- Product code
- EBD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040599 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK040599 Parkell Resin GlazeParkell, Inc. · 2004
- This deviceK080549 Durafinish All-Cure, Model S296Parkell, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040599 | Parkell Resin Glaze | Parkell, Inc. | 2004 | — |
| 0 (this device) | K080549 | Durafinish All-Cure, Model S296 | Parkell, Inc. | 2008 | — |
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? (1)
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 |
|---|---|---|---|
| * | K040599 | Parkell Resin GlazeSummary page 1…inish All-Cure Common Name: Resin Glaz,:r Classification Name: Coating, Filing Material, Resin Equivalence: Parkell Re&sin Glaze (K040599) Description/Intencied Use: DuraFinish All-Cure is a nano-filled, light-cured, clear resin intende… | 2004 |
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?
- Its one ancestor has no 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. 2008, 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?
A nano-filled, light-cured, clear resin intended for use by a duly licensed professional as a glaze and sealer for composite resin restorations; or for acrylic, bis-acryl and/or composite temporary materials. It can be used to impart high sheen and seal to appropriate surfaces without oxygen-inhibition and is expected to extend restoration durability and resistance to abrasive wear. Due to its photo-initiators, it may be cured by all common dental curing lights.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080549: Durafinish All-Cure, Model S296.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080549
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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