510(k) · Cleared
ClearedUltraTemp Rez II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultradent Products, Inc. · EMA Cement, Dental
Cleared on Jul 13, 2021 as substantially equivalent to K080768 (Ultradent Products, Inc., 2008) after a 78-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Jul 13, 2021
- Review
- 78 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K994261 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK994261 Ultratemp Temporary Polycarboxylate CementUltradent Products, Inc. · 2000
- 1 generation backK080768 Ultratemp Firm, Fast and Regular SetUltradent Products, Inc. · 2008
- This deviceK211237 UltraTemp Rez IIUltradent Products, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK261937 PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak · 2026
Most influential descendants
Showing 1 of 1 · See all- K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K994261 | Ultratemp Temporary Polycarboxylate Cement | Ultradent Products, Inc. | 2000 | — |
| −1 | K080768 | Ultratemp Firm, Fast and Regular Set | Ultradent Products, Inc. | 2008 | — |
| 0 (this device) | K211237 | UltraTemp Rez II | Ultradent Products, Inc. | 2021 | — |
| +1 | K261937 | PacTemp Automix NE | The Belport Company Inc., DBA Gingi-Pak | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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 |
|---|---|---|---|
| * | K080768 | Ultratemp Firm, Fast and Regular SetSummary page 5…ovisional crowns, bridges, inlays, and on lays) V. Predicate Device UltraTemp REZ II identified primary predicate: UltraTemp REZ (UltraTemp Firm, Fast and Regular Set (K080768) VII. Comparison of Technological Characteristics Predicate technological comparison: The technology, delivery, and intended us… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261937 | PacTemp Automix NE | 2026 | 0 |
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 21 years and passes through 1 company; a new generation was cleared every 13.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K261937 (The Belport Company Inc., DBA Gingi-Pak, 2026) has gone furthest, with 0 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. 2021, 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?
UltraTemp REZ II is indicated for temporization of provisional prosthesis or restorative procedures (i.e. provisional crowns, bridges, inlays, and on lays).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211237 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211237: UltraTemp Rez II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211237
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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