510(k) · Cleared
ClearedG aenial Universal Injectable II
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 Aug 29, 2025 as substantially equivalent to K173500 (GC America, Inc., 2018) and 2 other predicates after a 65-day review. Its family tree reaches back 12 generations to 1993.
- Decided
- Aug 29, 2025
- Review
- 65 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K931812 (1993). 69 ancestors in all, the oldest K833757 (1984). No later device cites it as a predicate yet.
- Root · 12 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 8 generations between
- 3 generations backK100756 MALTA3M Espe AG Dental Products · 2010
- 2 generations backK110508 Suglue-103M Espe AG · 2011
- 1 generation backK153231 G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc. · 2016
- This deviceK251946 G aenial Universal Injectable IIGC America, Inc. · 2025
Show all 12 generations
- Root · 12 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 11 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 10 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 9 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 8 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
- 7 generations backK990040 Clearfil SE BondKuraray Co. · 1999
- 6 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- 5 generations backK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
- 4 generations backK094007 Unicem3M Espe AG Dental Products · 2010
- 3 generations backK100756 MALTA3M Espe AG Dental Products · 2010
- 2 generations backK110508 Suglue-103M Espe AG · 2011
- 1 generation backK153231 G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc. · 2016
- This deviceK251946 G aenial Universal Injectable IIGC America, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −11 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −10 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −9 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −8 | K974486 | Clearfil Liner Bond 2V | Kuraray America, Inc. | 1998 | — |
| −7 | K990040 | Clearfil SE Bond | Kuraray Co. | 1999 | — |
| −6 | K012442 | Modification to Clearfil SE Bond | Kuraray Medical, Inc. | 2001 | — |
| −5 | K032455 | Panavia F 2.0 | Kuraray Medical, Inc. | 2003 | — |
| −4 | K094007 | Unicem | 3M Espe AG Dental Products | 2010 | — |
| −3 | K100756 | MALTA | 3M Espe AG Dental Products | 2010 | — |
| −2 | K110508 | Suglue-10 | 3M Espe AG | 2011 | — |
| −1 | K153231 | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer | GC America, Inc. | 2016 | — |
| 0 (this device) | K251946 | G aenial Universal Injectable II | GC America, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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 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? (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 |
|---|---|---|---|
| * | K173500 | NMF004ASummary page 5…es: Product Applicant 510(k) No. Code No. Predicate Decision Date Nmf004a GC America Inc. K173500 EBF Primary 03/08/2018 (G-ænial Universal Injectable) G-Cem LinkForce, Dual Cure GC America In… | 2018 |
| * | K153231 | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerSummary page 5…GC America Inc. K173500 EBF Primary 03/08/2018 (G-ænial Universal Injectable) G-Cem LinkForce, Dual Cure GC America Inc. K153231 EMA Secondary 07/06/2016 Activator, Try-In Paste, Multi Primer AlignerFlow LC… | 2016 |
| * | K231817 | AlignerFlow LCSummary page 5…erica Inc. K153231 EMA Secondary 07/06/2016 Activator, Try-In Paste, Multi Primer AlignerFlow LC Voco GmbH K231817 DYH Additional 12/01/2023 4. Description of Device: G-ænial Universal Injectable II is a light-cu… | 2023 |
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 32 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 69 ancestors have a recall of any class.
- 1 other device also cites its predicate K173500.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
1. Direct restorative for Class 1, 11, 111, IV, and V cavities
2. Fissure sealant
3. Sealing hypersensitive areas
4. Repair of (in)direct aesthetic restorations, temporary crown & bridge, defect margins when margins are in enamel
5. Blocking out undercuts
6. Liner or base
7. Core build-up
8. Adhesive cementation of ceramic and composite veneers, inlays and onlays with a thickness (<2.0 mm) and translucency that enables the complete light curing of the cement
9. Retention of aligner e.g. by fabrication of aligner attachments
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251946 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251946: G aenial Universal Injectable II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251946
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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