510(k) · Cleared
ClearedGDLS-200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GC America, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Nov 14, 2008 after an 81-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 44 later devices descend from it.
- Decided
- Nov 14, 2008
- Review
- 81 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
44 later devices descend from it, 5 citing it directly.
- This deviceK082434 GDLS-200GC America, Inc. · 2008
- Descendant · cites it directly · 43 of its ownK091388 GCUC-505GC America, Inc. · 2009
- Descendant · cites it directly · 39 of its ownK123631 MFP-051GC America, Inc. · 2013
- Descendant · 2 generations on · 32 of its ownK133824 CerasmartGC America, Inc. · 2014
- Descendant · 3 generations on · 26 of its ownK160425 CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc. · 2016
- Descendant · 4 generations on · 25 of its ownK162537 CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K091388GCUC-505GC America, Inc. · 2009 · cites it directly43descendants
- K123631MFP-051GC America, Inc. · 2013 · cites it directly39descendants
- K133824CerasmartGC America, Inc. · 2014 · 2 generations on32descendants
- K160425CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc. · 2016 · 3 generations on26descendants
- K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016 · 4 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082434 | GDLS-200 | GC America, Inc. | 2008 | — |
| +1 | K091388 | GCUC-505 | GC America, Inc. | 2009 | — |
| +1 | K123631 | MFP-051 | GC America, Inc. | 2013 | — |
| +2 | K133824 | Cerasmart | GC America, Inc. | 2014 | — |
| +3 | K160425 | CAD/CAMouflage Milling Bock | Prismatik Dentalcraft, Inc. | 2016 | — |
| +4 | K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 5 | 0 |
| 2026 | 6 | 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 EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 generations · 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? (44)
See all 445 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, K091388 (GC America, Inc., 2009) has gone furthest, with 43 descendants of its own.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
GDLS is a light-cured micro-filled radiopaque composite resin for the restoration of both anterior and posterior teeth. GDLS-200 consists of two delivery systems, Unitip (capsules for single dose) and Syringes. The GDLS-200 systems is available in a variety of shades.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K082434 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082434: GDLS-200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082434
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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