510(k) · Cleared
ClearedTemphase
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kerr Dental Materials Center · EBG Crown And Bridge, Temporary, Resin
Cleared on Feb 22, 2002 after a 43-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Feb 22, 2002
- Review
- 43 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK020092 TemphaseKerr Dental Materials Center · 2002
- Descendant · cites it directly · 2 of its ownK102917 Fixtemp C&BExacta Dental Direct, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK171729 Fixtemp C&BDreve Dentamid GmbH · 2017
- Descendant · 3 generations on · 0 of its ownK241226 Fixtemp® C&B 4:1Dreve Denatmid GmbH · 2024
- Descendant · cites it directly · 0 of its ownK052800 Provisional Inlay/Onlay KitDmg USA, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK021457 Flex Span Temporary Crown & Bridge MaterialPentron Corp. · 2002 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K102917Fixtemp C&BExacta Dental Direct, Inc. · 2011 · cites it directly2descendants
- K171729Fixtemp C&BDreve Dentamid GmbH · 2017 · 2 generations on1descendant
- K241226Fixtemp® C&B 4:1Dreve Denatmid GmbH · 2024 · 3 generations on0descendants
- K052800Provisional Inlay/Onlay KitDmg USA, Inc. · 2006 · cites it directly0descendants
- K021457Flex Span Temporary Crown & Bridge MaterialPentron Corp. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020092 | Temphase | Kerr Dental Materials Center | 2002 | — |
| +1 | K102917 | Fixtemp C&B | Exacta Dental Direct, Inc. | 2011 | — |
| +2 | K171729 | Fixtemp C&B | Dreve Dentamid GmbH | 2017 | — |
| +3 | K241226 | Fixtemp® C&B 4:1 | Dreve Denatmid GmbH | 2024 | — |
| +1 | K052800 | Provisional Inlay/Onlay Kit | Dmg USA, Inc. | 2006 | — |
| +1 | K021457 | Flex Span Temporary Crown & Bridge Material | Pentron Corp. | 2002 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | — | TempFil C&B Named without a submission number |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K102917 (Exacta Dental Direct, Inc., 2011) has gone furthest, with 2 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?
Temphase is a chemically catalyzed, highly filled, resin based restorative material used to
fabricate temporary crowns and bridges.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020092 · printed Nov 3, 2026
Cite this page
510(k) Report. “K020092: Temphase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020092
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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