510(k) · Cleared
ClearedKingscross PL-C+B-10, Kingscross PL-C+B-12, Kingscross PL-C+B-08, Kingscross B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kettenbach GmbH & Co. KG · EBG Crown And Bridge, Temporary, Resin
Cleared on Dec 27, 2012 as substantially equivalent to K853052 (Dentsply Intl., 1985) and 3 other predicates after a 169-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Dec 27, 2012
- Review
- 169 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K902115 (1990). 24 ancestors in all, the oldest K833757 (1984). No later device cites it as a predicate yet.
- Root · 5 generations backK902115 Palapress (R) Vario ResinKulzer, Inc. · 1990
- 4 generations backK972573 Liqcrylic Pro Dental ResinDentsply Intl. · 1997
- 3 generations backK991220 Vitron HEspe Dental AG · 1999
- 2 generations backK992645 SinfonyEspe Dental AG · 1999
- 1 generation backK073296 TEMPXN283M Espe AG Dental Products · 2008
- This deviceK122039 Kingscross PL-C+B-10, Kingscross PL-C+B-12, Kingscross PL-C+B-08…Kettenbach GmbH & Co. KG · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902115 | Palapress (R) Vario Resin | Kulzer, Inc. | 1990 | — |
| −4 | K972573 | Liqcrylic Pro Dental Resin | Dentsply Intl. | 1997 | — |
| −3 | K991220 | Vitron H | Espe Dental AG | 1999 | — |
| −2 | K992645 | Sinfony | Espe Dental AG | 1999 | — |
| −1 | K073296 | TEMPXN28 | 3M Espe AG Dental Products | 2008 | — |
| 0 (this device) | K122039 | Kingscross PL-C+B-10, Kingscross PL-C+B-12, Kingscross PL-C+B-08, Kingscross B | Kettenbach GmbH & Co. KG | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2010 | 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? (4)
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 |
|---|---|---|---|
| * | K853052 | IntegritySummary page 2…il a permanent restoration is fabricated. Predicate devices: Device Trade Name: Integrity Applicant: Dentsply Intl. 510(k) No.: K853052 Device Trade Name: Luxatemp Ultra/Star Applicant: DMG USA, Inc. 510O(k) No.: K101710 De… | 1985 |
| * | K101710 | Luxatemp Ultra /StarSummary page 2…Dentsply Intl. 510(k) No.: K853052 Device Trade Name: Luxatemp Ultra/Star Applicant: DMG USA, Inc. 510O(k) No.: K101710 Device Trade Name: Luxatemp Automix Applicant: DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH 510(k) No.:… | 2010 |
| * | K924830 | Luxatemp AutomixSummary page 2…o.: K101710 Device Trade Name: Luxatemp Automix Applicant: DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH 510(k) No.: K924830 Device Trade Name: Protemp Plus Applicant: 3M Espe 510O(k) No.: K073296… | 1994 |
| * | K073296 | TEMPXN28Summary page 2…PHARMAZEUTISCHE FABRIK GMBH 510(k) No.: K924830 Device Trade Name: Protemp Plus Applicant: 3M Espe 510O(k) No.: K073296 Substantial Equivalent Predicate Devices… | 2008 |
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 22 years and passes through 5 companies; a new generation was cleared every 5.0 years on median.
- None of the 24 ancestors has a recall.
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. 2012, 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?
Kingscross temporary crown and bridge material is intended to be used for fabrication of temporary prostheses, such as crowns, partial crowns, bridges, inlays, onlays and veneers, and for customization of prefabricated acrylic and metal crowns and for fabrication of long-term temporary restorations until a permanent restoration is fabricated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122039: Kingscross PL-C+B-10, Kingscross PL-C+B-12, Kingscross PL-C+B-08, Kingscross B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122039
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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