510(k) · Cleared
ClearedRmgi Fill
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulpdent Corporation · EMA Cement, Dental
Cleared on Mar 29, 2013 as substantially equivalent to K123265 (Pulpdent Corporation, 2012) and 2 other predicates after a 59-day review. Its family tree reaches back 4 generations to 1994. 4 later devices descend from it.
- Decided
- Mar 29, 2013
- Review
- 59 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K933139 (1994). 13 ancestors in all, the oldest K925032 (1992). 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK933139 3M Vitremer Luting Cement3M Company · 1994
- 3 generations backK022476 Relyx Rmgip3M Company · 2002
- 2 generations backK111185 Relyx Luting Plus Automix3M Espe Dental Products · 2011
- 1 generation backK123265 Rmgi Low ViscosityPulpdent Corporation · 2012
- This deviceK130223 Rmgi FillPulpdent Corporation · 2013
- Descendant · cites it directly · 1 of its ownK153249 Pulpdent Solo Flowable Composite with MCPPulpdent Corporation · 2016
- Descendant · cites it directly · 0 of its ownK250953 Equia LC OneGC America, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK210045 Activa Presto PackPulpdent Corporation · 2021
- Descendant · cites it directly · 0 of its ownK192530 Surefil one Self-adhesive Composite HybridDentsply Sirona · 2020
Most influential descendants
Showing 4 of 4 · See all- K153249Pulpdent Solo Flowable Composite with MCPPulpdent Corporation · 2016 · cites it directly1descendant
- K250953Equia LC OneGC America, Inc. · 2025 · cites it directly0descendants
- K210045Activa Presto PackPulpdent Corporation · 2021 · 2 generations on0descendants
- K192530Surefil one Self-adhesive Composite HybridDentsply Sirona · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933139 | 3M Vitremer Luting Cement | 3M Company | 1994 | — |
| −3 | K022476 | Relyx Rmgip | 3M Company | 2002 | — |
| −2 | K111185 | Relyx Luting Plus Automix | 3M Espe Dental Products | 2011 | — |
| −1 | K123265 | Rmgi Low Viscosity | Pulpdent Corporation | 2012 | — |
| 0 (this device) | K130223 | Rmgi Fill | Pulpdent Corporation | 2013 | — |
| +1 | K153249 | Pulpdent Solo Flowable Composite with MCP | Pulpdent Corporation | 2016 | — |
| +1 | K250953 | Equia LC One | GC America, Inc. | 2025 | — |
| +2 | K210045 | Activa Presto Pack | Pulpdent Corporation | 2021 | — |
| +1 | K192530 | Surefil one Self-adhesive Composite Hybrid | Dentsply Sirona | 2020 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K123265 | Rmgi Low ViscositySummary page 2…, base or Part A: Diurethane dimethacrylate and other RMGI Low Viscosity ionomer intwo pastes luting agent. methacrylate- based monomers and oligomers, K123265 polyacrylic acid/maleic acid copolymer, water, barium… | 2012 |
| * | K052235 | LCRSummary page 2…ionorner glass; BisGMA; PEGOMA; HEMA; TEGDMA. lonomer Restorative ionomer intwo pastes Part B: Silane-treated ceramic; co-polymer of acrylic K052235 and itaconic acids; HEMA; water, GC Light cure… | 2005 |
| * | K051427 | GC Fuji Fil LCSummary page 2…Dental restorative Part A: Aluminoflurosilicate ionomer glass; urethane Fuji Filling LC modified glass dimethacrylate; HEMA. K051427 ionomer intwo pastes Part B: Polyacrylic acid; water; amorphous, fumed… | 2005 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K153249 (Pulpdent Corporation, 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Pulpdent RMGI Fill is a resin-modified glass ionomer preparation used by dental professionals as filling material in dental restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130223: Rmgi Fill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130223
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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