510(k) · Cleared
ClearedLuxatemp/Luxatemp Solar/Instatemp
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 Jan 24, 2002 as substantially equivalent to K924830 (Dmg Chemisch Pharmazeutische Fabrik GmbH, 1994) and 2 other predicates after a 78-day review. Its family tree reaches back 1 generation to 1994. 11 later devices descend from it.
- Decided
- Jan 24, 2002
- Review
- 78 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K924830 (1994). 3 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK924830 Luxatemp AutomixDmg Chemisch Pharmazeutische Fabrik GmbH · 1994
- This deviceK013674 Luxatemp/Luxatemp Solar/InstatempDmg USA, Inc. · 2002
- Descendant · cites it directly · 7 of its ownK101710 Luxatemp Ultra /StarDmg USA, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK073296 TEMPXN283M Espe AG Dental Products · 2008
- Descendant · 2 generations on · 1 of its ownK200039 P pro Crown & BridgeDeltamed GmbH · 2020
- Descendant · 2 generations on · 0 of its ownK251271 TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK243370 DentaTOOTHAsiga Pty, Ltd. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K101710Luxatemp Ultra /StarDmg USA, Inc. · 2010 · cites it directly7descendants
- K073296TEMPXN283M Espe AG Dental Products · 2008 · cites it directly4descendants
- K200039P pro Crown & BridgeDeltamed GmbH · 2020 · 2 generations on1descendant
- K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd. · 2025 · 2 generations on0descendants
- K243370DentaTOOTHAsiga Pty, Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924830 | Luxatemp Automix | Dmg Chemisch Pharmazeutische Fabrik GmbH | 1994 | — |
| 0 (this device) | K013674 | Luxatemp/Luxatemp Solar/Instatemp | Dmg USA, Inc. | 2002 | — |
| +1 | K101710 | Luxatemp Ultra /Star | Dmg USA, Inc. | 2010 | — |
| +1 | K073296 | TEMPXN28 | 3M Espe AG Dental Products | 2008 | — |
| +2 | K200039 | P pro Crown & Bridge | Deltamed GmbH | 2020 | — |
| +2 | K251271 | TempFIT Temporary Crown and Bridge Resin | Rizhao Huge Biomaterials Company, Ltd. | 2025 | — |
| +3 | K243370 | DentaTOOTH | Asiga Pty, Ltd. | 2025 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K924830 | Luxatemp AutomixSummary page 1…omposition and physical properties, the proposed Luxatemp / InstaTemp material for attachment pickup usage is identical to the Luxatemp material cleared for marketing in K924830 and Luxatemp Solar material for attachment pickup usage is identical to the Iso-Temp material cleared for marketing in K944981 .… | 1994 |
| * | K944981 | 3M Tempcare Light Cure Temporary SystemSummary page 1…Luxatemp material cleared for marketing in K924830 and Luxatemp Solar material for attachment pickup usage is identical to the Iso-Temp material cleared for marketing in K944981 . The inclusion of attachment pickup techniques in the product labeling is similar to that found in the labeling for the DMG USA,… | 1994 |
| * | K011211 | Flowable Composite/ Ecuflow/ Luxaflow | 2001 |
What descends from it? (11)
See all 112 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?
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?
Luxatemp / InstaTemp are self-cure provisional crown and bridge composites for use in temporary crowns and bridges, long-term temporaries, inlays and onlays.
Luxatemp Solar is a dual-cure provisional crown and bridge composite for use in temporary crowns and bridges, long-term temporaries, inlays and onlays.
Luxatemp / Luxatemp Solar / InstaTemp are 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/K013674 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013674: Luxatemp/Luxatemp Solar/Instatemp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013674
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026