510(k) · Cleared
ClearedG-Cem Universal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GC America, Inc. · EMA Cement, Dental
Cleared on May 18, 2026 as substantially equivalent to K200798 (GC America, Inc., 2020) after a 150-day review. Its family tree reaches back 13 generations to 1993.
- Decided
- May 18, 2026
- Review
- 150 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K931812 (1993). 62 ancestors in all, the oldest K833757 (1984). No later device cites it as a predicate yet.
- Root · 13 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 9 generations between
- 3 generations backK110508 Suglue-103M Espe AG · 2011
- 2 generations backK153231 G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc. · 2016
- 1 generation backK200798 G-Cem OneGC America, Inc. · 2020
- This deviceK254109 G-Cem UniversalGC America, Inc. · 2026
Show all 13 generations
- Root · 13 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 12 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 11 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 10 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 9 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
- 8 generations backK990040 Clearfil SE BondKuraray Co. · 1999
- 7 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- 6 generations backK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
- 5 generations backK094007 Unicem3M Espe AG Dental Products · 2010
- 4 generations backK100756 MALTA3M Espe AG Dental Products · 2010
- 3 generations backK110508 Suglue-103M Espe AG · 2011
- 2 generations backK153231 G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc. · 2016
- 1 generation backK200798 G-Cem OneGC America, Inc. · 2020
- This deviceK254109 G-Cem UniversalGC America, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −12 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −11 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −10 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −9 | K974486 | Clearfil Liner Bond 2V | Kuraray America, Inc. | 1998 | — |
| −8 | K990040 | Clearfil SE Bond | Kuraray Co. | 1999 | — |
| −7 | K012442 | Modification to Clearfil SE Bond | Kuraray Medical, Inc. | 2001 | — |
| −6 | K032455 | Panavia F 2.0 | Kuraray Medical, Inc. | 2003 | — |
| −5 | K094007 | Unicem | 3M Espe AG Dental Products | 2010 | — |
| −4 | K100756 | MALTA | 3M Espe AG Dental Products | 2010 | — |
| −3 | K110508 | Suglue-10 | 3M Espe AG | 2011 | — |
| −2 | K153231 | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer | GC America, Inc. | 2016 | — |
| −1 | K200798 | G-Cem One | GC America, Inc. | 2020 | — |
| 0 (this device) | K254109 | G-Cem Universal | GC America, Inc. | 2026 | — |
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 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 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 K261166 Dia-Cemscore 14.3 · 10 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 |
|---|---|---|---|
| * | K200798 | G-Cem OneSummary page 5…DEVICE Product Applicant 510(k) No. Code No. Predicate Decision Date G-CEM ONE GC America Inc. K200798 EMA Primary 11/24/2020 4. DEVICE DESCRIPTION G-CEM Universal is a dual-cure, self-adhesive resin c… | 2020 |
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 33 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 62 ancestors have a recall of any class.
- 2 other devices also cite its predicate K200798.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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. Cementation of all types of all ceramic, resin, and metal-based inlays, onlays, crowns and bridges.
2. Cementation of metal, ceramic, fiber posts, and cast post and cores.
3. Cementation of all ceramic and composite veneers.
4. Final cementation of crowns and bridges on implant abutments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254109: G-Cem Universal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254109
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026