510(k) · Cleared
ClearediCEM Universal Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kulzer, LLC · EMA Cement, Dental
Cleared on Dec 19, 2025 as substantially equivalent to K200798 (GC America, Inc., 2020) after a 2-day review. Its family tree reaches back 13 generations to 1993.
- Decided
- Dec 19, 2025
- Review
- 2 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 deviceK254063 iCEM Universal PlusKulzer, LLC · 2025
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 deviceK254063 iCEM Universal PlusKulzer, LLC · 2025
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) | K254063 | iCEM Universal Plus | Kulzer, LLC | 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 | 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 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? (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…al Plus Common Name: Dental cement Classification Name: Cement, Dental Regulation Number: 872.3275 Product Code(s): EMA Legally Marketed Predicate Devices Predicate #: K200798 Predicate Trade Name: G-CEM ONE Product Code(s): EMA Device Description Summary The subject device is a dual-cure resin cement… | 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 32 years and passes through 8 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. 2025, 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?
Bonding of indirect restorations made of composite, all-ceramic and metal.
Bonding of prosthetic devices (crowns, inlays, onlays, bridges, and veneers) to cavities, abutment teeth, or implant abutments.
Dental core bonding.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K254063 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254063: iCEM Universal Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254063
Report an extraction error
Are you the manufacturer?
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