510(k) · Cleared
ClearedLuxatemp Ultra /Star
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dmg USA, Inc. · EBG Crown And Bridge, Temporary, Resin
Cleared on Sep 28, 2010 as substantially equivalent to K013674 (Dmg USA, Inc., 2002) after a 103-day review. Its family tree reaches back 2 generations to 1994. 7 later devices descend from it.
- Decided
- Sep 28, 2010
- Review
- 103 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K924830 (1994). 4 ancestors in all. 7 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK924830 Luxatemp AutomixDmg Chemisch Pharmazeutische Fabrik GmbH · 1994
- 1 generation backK013674 Luxatemp/Luxatemp Solar/InstatempDmg USA, Inc. · 2002
- This deviceK101710 Luxatemp Ultra /StarDmg USA, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK200039 P pro Crown & BridgeDeltamed GmbH · 2020
- Descendant · cites it directly · 0 of its ownK251271 TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK243370 DentaTOOTHAsiga Pty, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK191619 TurboTemp EZZest Anchors, LLC · 2019
- Descendant · cites it directly · 0 of its ownK190930 SmarTemp X1Parkell, Inc. · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K200039P pro Crown & BridgeDeltamed GmbH · 2020 · cites it directly1descendant
- K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd. · 2025 · cites it directly0descendants
- K243370DentaTOOTHAsiga Pty, Ltd. · 2025 · 2 generations on0descendants
- K191619TurboTemp EZZest Anchors, LLC · 2019 · cites it directly0descendants
- K190930SmarTemp X1Parkell, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924830 | Luxatemp Automix | Dmg Chemisch Pharmazeutische Fabrik GmbH | 1994 | — |
| −1 | K013674 | Luxatemp/Luxatemp Solar/Instatemp | Dmg USA, Inc. | 2002 | — |
| 0 (this device) | K101710 | Luxatemp Ultra /Star | Dmg USA, Inc. | 2010 | — |
| +1 | K200039 | P pro Crown & Bridge | Deltamed GmbH | 2020 | — |
| +1 | K251271 | TempFIT Temporary Crown and Bridge Resin | Rizhao Huge Biomaterials Company, Ltd. | 2025 | — |
| +2 | K243370 | DentaTOOTH | Asiga Pty, Ltd. | 2025 | — |
| +1 | K191619 | TurboTemp EZ | Zest Anchors, LLC | 2019 | — |
| +1 | K190930 | SmarTemp X1 | Parkell, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K013674 | Luxatemp/Luxatemp Solar/InstatempSummary page 1…r the same material Predicate Device: Luxatemp Ultra/Star is substantially equivalent to the currently marketed DMG USA Luxatemp and Luxatemp Solar products cleared in K013674. Luxatemp / Luxatemp Solar and Luxatemp Ultra/Star differ only slightly in material composition, resulting in improved material p… | 2002 |
What descends from it? (7)
6 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?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K200039 (Deltamed GmbH, 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K013674.
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. 2010, 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?
Luxatemp Ultra/Star is a self-curing or dual-curing composite for the fabrication of
temporary crowns and bridges, inlays, onlays and veneers.
Luxatemp Ultra/Star is intended for the fabrication of:
temporary crowns
bridges
inlays
onlays
long-term temporaries
temporary veneers
Luxatemp Ultra/Star is also indicated for incorporation of most mechanically anchored
attachment components into the acrylic base of a denture, an overdenture or partial
denture.
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/K101710 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101710: Luxatemp Ultra /Star.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101710
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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