510(k) · Cleared
ClearedEquia LC One
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 Sep 19, 2025 as substantially equivalent to K130223 (Pulpdent Corporation, 2013) after a 175-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Sep 19, 2025
- Review
- 175 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K933139 (1994). 14 ancestors in all, the oldest K925032 (1992). No later device cites it as a predicate yet.
- Root · 5 generations backK933139 3M Vitremer Luting Cement3M Company · 1994
- 4 generations backK022476 Relyx Rmgip3M Company · 2002
- 3 generations backK111185 Relyx Luting Plus Automix3M Espe Dental Products · 2011
- 2 generations backK123265 Rmgi Low ViscosityPulpdent Corporation · 2012
- 1 generation backK130223 Rmgi FillPulpdent Corporation · 2013
- This deviceK250953 Equia LC OneGC America, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933139 | 3M Vitremer Luting Cement | 3M Company | 1994 | — |
| −4 | K022476 | Relyx Rmgip | 3M Company | 2002 | — |
| −3 | K111185 | Relyx Luting Plus Automix | 3M Espe Dental Products | 2011 | — |
| −2 | K123265 | Rmgi Low Viscosity | Pulpdent Corporation | 2012 | — |
| −1 | K130223 | Rmgi Fill | Pulpdent Corporation | 2013 | — |
| 0 (this device) | K250953 | Equia LC One | GC America, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K130223 | Rmgi FillSummary page 5…Product Applicant 510(k) No. Code No. Predicate Decision Date Pulpdent ACTIVA BioAC- Pulpdent Corpora- K130223 EMA Primary 03/29/2013 TIVE RESTORATIVE tion (Pulpdent RMGI Fill) GC Fuji Automi… | 2013 |
| † | K172382 | GC Fuji Direct | 2018 |
| † | K993973 | Fuji II LC Capsule | 2000 |
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 31 years and passes through 4 companies; a new generation was cleared every 8.6 years on median.
- None of the 14 ancestors has a recall.
- 2 other devices also cite its predicate K130223.
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?
1. Class I, II, III, IV and V restorations
2. Root surface restoration
3. Core build-up
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250953 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250953: Equia LC One.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250953
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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