510(k) · Cleared
ClearedGilb-2, Glass Ionomer Protective Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Espe Dental Products · EMA Cement, Dental
Cleared on Jan 17, 2008 as substantially equivalent to K011200 (3M Company, 2001) and 2 other predicates after a 45-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Jan 17, 2008
- Review
- 45 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K011200 (2001). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK011200 Gilb, Model 80103M Company · 2001
- This deviceK073395 Gilb-2, Glass Ionomer Protective Coating3M Espe Dental Products · 2008
- Descendant · cites it directly · 2 of its ownK091632 SPK Sealant3M Company · 2009
- Descendant · 2 generations on · 1 of its ownK100062 Infiltration KitDmg USA, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK251124 G-Bond UniversalGC America, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011200 | Gilb, Model 8010 | 3M Company | 2001 | — |
| 0 (this device) | K073395 | Gilb-2, Glass Ionomer Protective Coating | 3M Espe Dental Products | 2008 | — |
| +1 | K091632 | SPK Sealant | 3M Company | 2009 | — |
| +2 | K100062 | Infiltration Kit | Dmg USA, Inc. | 2010 | — |
| +3 | K251124 | G-Bond Universal | GC America, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 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 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? (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 |
|---|---|---|---|
| * | K011200 | Gilb, Model 8010Summary page 1…Dental Cement Predicate Devices Device 51 0(k Vitrebond Plus K01 1200 Euji VII Capsule (Fuji Triage) K01 3198 Embrace Wetbond Clear Sealant… | 2001 |
| * | K013198 | Fuji Vii CapsuleSummary page 1…51 0(k Vitrebond Plus K01 1200 Euji VII Capsule (Fuji Triage) K01 3198 Embrace Wetbond Clear Sealant K052281 Description and Technology Equivalence GILB-2, Glass I… | 2001 |
| * | K052281 | Embrace Wetbond Clear SealantSummary page 1…K01 1200 Euji VII Capsule (Fuji Triage) K01 3198 Embrace Wetbond Clear Sealant K052281 Description and Technology Equivalence GILB-2, Glass Ionomer protective coating is classified as Dental Cement (21 C.F.R§872.3… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091632 | SPK Sealant | 2009 | 2 |
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?
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 | — |
What is it indicated for?
1. Lining and basing applications under composite, amalgam, ceramic or metal restorations.
2. Treatment of exposed root surface sensitivity
3. Site specific protective coating for newly erupted teeth and other tooth surfaces including non-cavitated lesions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073395: Gilb-2, Glass Ionomer Protective Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073395
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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