510(k) · Cleared
ClearedGilb, Model 8010
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · EMA Cement, Dental
Cleared on Jun 14, 2001 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jun 14, 2001
- Review
- 56 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK011200 Gilb, Model 80103M Company · 2001
- 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 ownK230270 3M™ VitCal Liner/Base3M Espe Dental Products · 2023
- Descendant · 3 generations on · 1 of its ownK100062 Infiltration KitDmg USA, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK261728 One-Fil LCMediclus Co., Ltd. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K073395Gilb-2, Glass Ionomer Protective Coating3M Espe Dental Products · 2008 · cites it directly3descendants
- K091632SPK Sealant3M Company · 2009 · 2 generations on2descendants
- K2302703M™ VitCal Liner/Base3M Espe Dental Products · 2023 · cites it directly1descendant
- K100062Infiltration KitDmg USA, Inc. · 2010 · 3 generations on1descendant
- K261728One-Fil LCMediclus Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011200 | Gilb, Model 8010 | 3M Company | 2001 | — |
| +1 | K073395 | Gilb-2, Glass Ionomer Protective Coating | 3M Espe Dental Products | 2008 | — |
| +2 | K091632 | SPK Sealant | 3M Company | 2009 | — |
| +1 | K230270 | 3M™ VitCal Liner/Base | 3M Espe Dental Products | 2023 | — |
| +3 | K100062 | Infiltration Kit | Dmg USA, Inc. | 2010 | — |
| +2 | K261728 | One-Fil LC | Mediclus Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EMA? 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 EMA device
- #1 K254109 G-Cem Universalscore 15.0 · 13 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
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, K073395 (3M Espe Dental Products, 2008) has gone furthest, with 3 descendants of its own.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EMA
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EMA
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EMA
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EMA
9in 2025
MAUDE reports naming product code EMA, 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 | 6 | 48 | 0 | 33 |
| 2008 | 13 | 71 | 2 | 50 |
| 2009 | 10 | 86 | 1 | 90 |
| 2010 | 14 | 86 | 1 | 106 |
| 2011 | 8 | 79 | 5 | 224 |
| 2012 | 10 | 128 | 0 | 249 |
| 2013 | 12 | 178 | 0 | 385 |
| 2014 | 4 | 174 | 0 | 207 |
| 2015 | 9 | 134 | 0 | 85 |
| 2016 | 10 | 182 | 0 | 16 |
| 2017 | 3 | 141 | 0 | 13 |
| 2018 | 3 | 237 | 0 | 4 |
| 2019 | 7 | 127 | 0 | 12 |
| 2020 | 8 | 164 | 0 | 5 |
| 2021 | 4 | 184 | 0 | 8 |
| 2022 | 7 | 245 | 0 | 3 |
| 2023 | 2 | — | 1 | 6 |
| 2024 | 3 | 59 | 0 | 5 |
| 2025 | 10 | 106 | 0 | 9 |
| 2026 | 7 | 150 | 0 | — |
https://510kreport.com/device/K011200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011200: Gilb, Model 8010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011200
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026