510(k) · Cleared
ClearedRelyx Luting Plus Automix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Espe Dental Products · EMA Cement, Dental
Cleared on May 5, 2011 as substantially equivalent to K022476 (3M Company, 2002) after an 8-day review. Its family tree reaches back 2 generations to 1994. 10 later devices descend from it.
- Decided
- May 5, 2011
- Review
- 8 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K933139 (1994). 3 ancestors in all. 10 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK933139 3M Vitremer Luting Cement3M Company · 1994
- 1 generation backK022476 Relyx Rmgip3M Company · 2002
- This deviceK111185 Relyx Luting Plus Automix3M Espe Dental Products · 2011
- Descendant · cites it directly · 5 of its ownK123265 Rmgi Low ViscosityPulpdent Corporation · 2012
- Descendant · 2 generations on · 4 of its ownK130223 Rmgi FillPulpdent Corporation · 2013
- Descendant · 3 generations on · 1 of its ownK153249 Pulpdent Solo Flowable Composite with MCPPulpdent Corporation · 2016
- Descendant · 3 generations on · 0 of its ownK250953 Equia LC OneGC America, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK250566 EsCem RMGISpident Co., Ltd. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K123265Rmgi Low ViscosityPulpdent Corporation · 2012 · cites it directly5descendants
- K130223Rmgi FillPulpdent Corporation · 2013 · 2 generations on4descendants
- K153249Pulpdent Solo Flowable Composite with MCPPulpdent Corporation · 2016 · 3 generations on1descendant
- K250953Equia LC OneGC America, Inc. · 2025 · 3 generations on0descendants
- K250566EsCem RMGISpident Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933139 | 3M Vitremer Luting Cement | 3M Company | 1994 | — |
| −1 | K022476 | Relyx Rmgip | 3M Company | 2002 | — |
| 0 (this device) | K111185 | Relyx Luting Plus Automix | 3M Espe Dental Products | 2011 | — |
| +1 | K123265 | Rmgi Low Viscosity | Pulpdent Corporation | 2012 | — |
| +2 | K130223 | Rmgi Fill | Pulpdent Corporation | 2013 | — |
| +3 | K153249 | Pulpdent Solo Flowable Composite with MCP | Pulpdent Corporation | 2016 | — |
| +3 | K250953 | Equia LC One | GC America, Inc. | 2025 | — |
| +1 | K250566 | EsCem RMGI | Spident Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 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? (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 |
|---|---|---|---|
| * | K022476 | Relyx RmgipSummary page 1…(2l CFR 872.3275, Product Code: EMA) Predicate Devices: 3MTM ESPETM RelyXTm Luting Plus Cement (K022476) Description of Device: 3MTm ESPETMI Re~yXTM Luting Plus Automix (Lexus-2) is a radiopaque,… | 2002 |
What descends from it? (10)
5 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 17 years and passes through 2 companies; a new generation was cleared every 8.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K123265 (Pulpdent Corporation, 2012) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K022476.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
This device is intended for use as a dental cement. RelyX TM Luting Plus Automix (Lexus-2) is indicated for Luting:
* Lutiing porcelain fused to metal crowns and bridges to tooth structure, amalgam, composite or glass janomer 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 Procerag AlICeram
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111185: Relyx Luting Plus Automix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111185
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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