510(k) · Cleared
ClearedFixtemp C&B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dreve Dentamid GmbH · EBG Crown And Bridge, Temporary, Resin
Cleared on Dec 13, 2017 as substantially equivalent to K102917 (Exacta Dental Direct, Inc., 2011) after a 184-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Dec 13, 2017
- Review
- 184 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020092 (2002). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K241226Fixtemp® C&B 4:1Dreve Denatmid GmbH · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020092 | Temphase | Kerr Dental Materials Center | 2002 | — |
| −1 | K102917 | Fixtemp C&B | Exacta Dental Direct, Inc. | 2011 | — |
| 0 (this device) | K171729 | Fixtemp C&B | Dreve Dentamid GmbH | 2017 | — |
| +1 | K241226 | Fixtemp® C&B 4:1 | Dreve Denatmid GmbH | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K102917 | Fixtemp C&BSummary page 4…C&B resin Fixtemp® C&B D60391, D60392, D603925, D60393, D603935, D60394, D60395, D60396, D60399 Crown and bridge, Temporary, Resin Class 2 per 21 CFR 872.3770 EBG K102917 FixTemp C&B'™ Fixtemp® C&B is a two-component automatically mixable composite on the basis of multifunctional (meth)acrylates pr… | 2011 |
| † | K122039 | Kingscross PL-C+B-10, Kingscross PL-C+B-12, Kingscross PL-C+B-08, Kingscross B | 2012 |
| † | K033022 | Protemp 3 Garant | 2003 |
| † | K042820 | Systemp.C&B Plus | 2004 |
| † | K013674 | Luxatemp/Luxatemp Solar/Instatemp | 2002 |
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 |
|---|---|---|---|
| K241226 | Fixtemp® C&B 4:1 | 2024 | 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 15 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K241226 (Dreve Denatmid GmbH, 2024) 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. 2017, 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?
Fixtemp® C&B is a resin based 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/K171729 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171729: Fixtemp C&B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171729
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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