510(k) · Cleared
ClearedTuff-Temp 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulpdent Corporation · EBG Crown And Bridge, Temporary, Resin
Cleared on Jun 8, 2012 as substantially equivalent to K081810 (Pulpdent Corporation, 2008) after an 85-day review. Its family tree reaches back 1 generation to 2008. 6 later devices descend from it.
- Decided
- Jun 8, 2012
- Review
- 85 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K081810 (2008). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK081810 Pulpdent Temporary Crown and Bridge MaterialPulpdent Corporation · 2008
- This deviceK120784 Tuff-Temp 2.0Pulpdent Corporation · 2012
- 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 · 4 generations on · 0 of its ownK210045 Activa Presto PackPulpdent Corporation · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · 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
- K210045Activa Presto PackPulpdent Corporation · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K081810 | Pulpdent Temporary Crown and Bridge Material | Pulpdent Corporation | 2008 | — |
| 0 (this device) | K120784 | Tuff-Temp 2.0 | Pulpdent Corporation | 2012 | — |
| +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 | — |
| +4 | K210045 | Activa Presto Pack | Pulpdent Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 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 EBG? 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 EBG device
- #1 K253380 “FLNT Base” and “FLNT Temp”score 12.4 · 6 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081810 | Pulpdent Temporary Crown and Bridge MaterialSummary page 1…o make a temporary Blended dimethacrylate resins composite material in prosthesis, such as a crown Chemical and Photo-initiators K081810 .two parts or bridge, for use until a Bhmgasadsbirnslc ilr… | 2008 |
| Kept off the family tree | K013674 | FDA’s K013674 is Luxatemp/Luxatemp Solar/Instatemp Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2002 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123265 | Rmgi Low Viscosity | 2012 | 5 |
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?
- Its one ancestor has no recall.
- Of its descendants, K123265 (Pulpdent Corporation, 2012) has gone furthest, with 5 descendants of its own.
How does its category compare?
All EBG devicesEBG Crown And Bridge, Temporary, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · EBG
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBG
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBG
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBG
1in 2025
MAUDE reports naming product code EBG, 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 | 3 | 64 | 0 | 4 |
| 2008 | 9 | 83 | 0 | 4 |
| 2009 | 2 | — | 1 | 1 |
| 2010 | 5 | 103 | 0 | 1 |
| 2011 | 10 | 96 | 0 | 1 |
| 2012 | 5 | 90 | 0 | 5 |
| 2013 | 2 | — | 0 | 11 |
| 2014 | 3 | 114 | 0 | 23 |
| 2015 | 6 | 209 | 0 | 26 |
| 2016 | 4 | 163 | 0 | 8 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 4 | 202 | 0 | 0 |
| 2019 | 6 | 98 | 0 | 6 |
| 2020 | 14 | 194 | 1 | 2 |
| 2021 | 3 | 265 | 0 | 4 |
| 2022 | 3 | 73 | 0 | 2 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 5 | 144 | 0 | 0 |
| 2025 | 4 | 106 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Pulpdent Tuff-Temp 2.0 is a dual-cure, glass-filled, resin composite used by the dental professional to make a temporary prosthesis, such as a crown or bridge, to be used until a permanent restoration can be fabricated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120784: Tuff-Temp 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120784
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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