510(k) · Cleared
ClearedRiva Luting Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Southern Dental Industries, Inc. · EMA Cement, Dental
Cleared on Nov 15, 2006 after a 118-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 96 later devices descend from it.
- Decided
- Nov 15, 2006
- Review
- 118 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 0
96 later devices descend from it, 1 citing it directly.
- This deviceK062065 Riva Luting PlusSouthern Dental Industries, Inc. · 2006
- Descendant · cites it directly · 95 of its ownK071945 S4 Spinal SystemAesculap Implant Systems · 2007
- Descendant · 2 generations on · 94 of its ownK090657 Modification to: S4 Spinal SystemAesculap Implant Systems · 2009
- Descendant · 2 generations on · 92 of its ownK100623 Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems · 2010 · Recalled
- Descendant · 2 generations on · 61 of its ownK112551 S4 Spinal SystemAesculap Implant System, Inc. · 2011
- Descendant · 3 generations on · 51 of its ownK123352 S4 Spinal SystemAesculap Implant Systems, Inc. · 2012
Showing 5 of 96 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 96 · See all- K071945S4 Spinal SystemAesculap Implant Systems · 2007 · cites it directly95descendants
- K090657Modification to: S4 Spinal SystemAesculap Implant Systems · 2009 · 2 generations on94descendants
- K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems · 2010 · 2 generations on92descendants
- K112551S4 Spinal SystemAesculap Implant System, Inc. · 2011 · 2 generations on61descendants
- K123352S4 Spinal SystemAesculap Implant Systems, Inc. · 2012 · 3 generations on51descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062065 | Riva Luting Plus | Southern Dental Industries, Inc. | 2006 | — |
| +1 | K071945 | S4 Spinal System | Aesculap Implant Systems | 2007 | — |
| +2 | K090657 | Modification to: S4 Spinal System | Aesculap Implant Systems | 2009 | — |
| +2 | K100623 | Aesculap Implant Systems S4 Spinal System | Aesculap Implant Systems | 2010 | 1 |
| +2 | K112551 | S4 Spinal System | Aesculap Implant System, Inc. | 2011 | — |
| +3 | K123352 | S4 Spinal System | Aesculap Implant Systems, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 12 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 8 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 14 | 0 |
| 2024 | 12 | 0 |
| 2025 | 10 | 0 |
| 2026 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (96)
See all 961 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071945 | S4 Spinal System | 2007 | 95 |
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?
- Of its descendants, K071945 (Aesculap Implant Systems, 2007) has gone furthest, with 95 descendants 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.
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?
Cementation of metal free or porcelain fused to metal inlays, onlays, bridges and crowns.
Cementation of stainless steel crowns.
Cementation of posts and screws.
Attachment of metal orthodontic bands.
Base or liner.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K062065 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062065: Riva Luting Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062065
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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