510(k) · Cleared
ClearedRelyx Rmgip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · EMA Cement, Dental
Cleared on Aug 2, 2002 as substantially equivalent to K933139 (3M Company, 1994) and 1 other predicate after a 4-day review. Its family tree reaches back 1 generation to 1994. 15 later devices descend from it.
- Decided
- Aug 2, 2002
- Review
- 4 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K933139 (1994). 2 ancestors in all. 15 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK933139 3M Vitremer Luting Cement3M Company · 1994
- This deviceK022476 Relyx Rmgip3M Company · 2002
- Descendant · cites it directly · 10 of its ownK111185 Relyx Luting Plus Automix3M Espe Dental Products · 2011
- Descendant · 2 generations on · 5 of its ownK123265 Rmgi Low ViscosityPulpdent Corporation · 2012
- Descendant · 3 generations on · 4 of its ownK130223 Rmgi FillPulpdent Corporation · 2013
- Descendant · 4 generations on · 1 of its ownK153249 Pulpdent Solo Flowable Composite with MCPPulpdent Corporation · 2016
- Descendant · cites it directly · 1 of its ownK121804 Provitemp, Dentotemp, Totalcem, DentocemItena Clinical · 2013
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K111185Relyx Luting Plus Automix3M Espe Dental Products · 2011 · cites it directly10descendants
- K123265Rmgi Low ViscosityPulpdent Corporation · 2012 · 2 generations on5descendants
- K130223Rmgi FillPulpdent Corporation · 2013 · 3 generations on4descendants
- K153249Pulpdent Solo Flowable Composite with MCPPulpdent Corporation · 2016 · 4 generations on1descendant
- K121804Provitemp, Dentotemp, Totalcem, DentocemItena Clinical · 2013 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933139 | 3M Vitremer Luting Cement | 3M Company | 1994 | — |
| 0 (this device) | K022476 | Relyx Rmgip | 3M Company | 2002 | — |
| +1 | K111185 | Relyx Luting Plus Automix | 3M Espe Dental Products | 2011 | — |
| +2 | K123265 | Rmgi Low Viscosity | Pulpdent Corporation | 2012 | — |
| +3 | K130223 | Rmgi Fill | Pulpdent Corporation | 2013 | — |
| +4 | K153249 | Pulpdent Solo Flowable Composite with MCP | Pulpdent Corporation | 2016 | — |
| +1 | K121804 | Provitemp, Dentotemp, Totalcem, Dentocem | Itena Clinical | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K933139 | 3M Vitremer Luting CementSummary page 1…mmon Name: ...................................... Luting Cement Predicate Device: RelyX Luting Cement ............................. K 933139 GC FujiCEM .................................. K 001730 Description for the Premarket Notification… | 1994 |
| * | K001730 | GC FujicemSummary page 1…dicate Device: RelyX Luting Cement ............................. K 933139 GC FujiCEM .................................. K 001730 Description for the Premarket Notification RelyX RMGIP is classified as a Dental Cement (21 C.F.R. 0 872.… | 2000 |
What descends from it? (15)
See all 154 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?
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Luting porcelain fused to metal crowns and bridges to tooth structure, amalgam, composite or glass ionomer core build ups;
Luting metal inlays, onlays or crowns;
Luting pre-fabricated and cast post cementation
Luting orthodontic appliances
Luting crowns made with all-alumina or all-zirconia cores such as ProceraB AllCeram
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022476 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022476: Relyx Rmgip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022476
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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