510(k) · Cleared
ClearedPacTemp Automix NE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Belport Company Inc., DBA Gingi-Pak · EMA Cement, Dental
Cleared on Aug 7, 2026 as substantially equivalent to K211237 (Ultradent Products, Inc., 2021) after a 58-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Aug 7, 2026
- Review
- 58 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K994261 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK994261 Ultratemp Temporary Polycarboxylate CementUltradent Products, Inc. · 2000
- 2 generations backK080768 Ultratemp Firm, Fast and Regular SetUltradent Products, Inc. · 2008
- 1 generation backK211237 UltraTemp Rez IIUltradent Products, Inc. · 2021
- This deviceK261937 PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K994261 | Ultratemp Temporary Polycarboxylate Cement | Ultradent Products, Inc. | 2000 | — |
| −2 | K080768 | Ultratemp Firm, Fast and Regular Set | Ultradent Products, Inc. | 2008 | — |
| −1 | K211237 | UltraTemp Rez II | Ultradent Products, Inc. | 2021 | — |
| 0 (this device) | K261937 | PacTemp Automix NE | The Belport Company Inc., DBA Gingi-Pak | 2026 | — |
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 |
|---|---|---|---|
| * | K211237 | UltraTemp Rez IISummary page 5…ures, including provisional crowns, bridges, inlays, and onlays. Predicate Device The following legally marketed device was used as the predicate device: 510(k) Number: K211237 Summary_PacTemp Automix NE_Rev.062426 Page 1 of 4 510(k) Tra… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
PacTemp Automix NE is indicated for temporization of provisional prostheses or restorative procedures, including provisional crowns, bridges, inlays, and onlays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261937 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261937: PacTemp Automix NE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261937
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026