510(k) · Cleared
ClearedTempfx Esthetic Provisional System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply International, Inc. · EBG Crown And Bridge, Temporary, Resin
Cleared on May 23, 2006 as substantially equivalent to K904251 (Dentifax Intern, Inc., 1991) after an 18-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- May 23, 2006
- Review
- 18 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K904251 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK904251 New Triad VLC Crown & Bridge Provisional MaterialDentifax Intern, Inc. · 1991
- This deviceK061264 Tempfx Esthetic Provisional SystemDentsply International, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK080311 Modified Temprx Esthetic Provisional SystemDentsply Interntional · 2008
Most influential descendants
Showing 1 of 1 · See all- K080311Modified Temprx Esthetic Provisional SystemDentsply Interntional · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904251 | New Triad VLC Crown & Bridge Provisional Material | Dentifax Intern, Inc. | 1991 | — |
| 0 (this device) | K061264 | Tempfx Esthetic Provisional System | Dentsply International, Inc. | 2006 | — |
| +1 | K080311 | Modified Temprx Esthetic Provisional System | Dentsply Interntional | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (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 |
|---|---|---|---|
| * | K904251 | New Triad VLC Crown & Bridge Provisional MaterialSummary page 1…wn and bridge resin, 872.3770 PREDICATE DEVICES: New Triad VLC Crown & Bridge Provisional Material, K90425 1 DEVICE DESCRIPTION: The TEMPEX ESTHETIC PROVISIONAL SYSTEM includes visible light cured resin based composites and accessorie… | 1991 |
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 |
|---|---|---|---|
| K080311 | Modified Temprx Esthetic Provisional System | 2008 | 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?
- Its one ancestor has no recall.
- Of its descendants, K080311 (Dentsply Interntional, 2008) has gone furthest, with 0 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.
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?
TEMPFX ESTHETIC PROVISIONAL SYSTEM is indicated for fabrication of provisional
dental restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061264 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061264: Tempfx Esthetic Provisional System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061264
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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