510(k) · Cleared
ClearedE-Temp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Envisiontec GmbH · EBG Crown And Bridge, Temporary, Resin
Cleared on Jun 14, 2021 as substantially equivalent to K102776 (Deltamed GmbH, 2011) after a 62-day review. Its family tree reaches back 2 generations to 2007. 2 later devices descend from it.
- Decided
- Jun 14, 2021
- Review
- 62 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K070991 (2007). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK070991 Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102…Vita · 2007
- 1 generation backK102776 Extra-Oral, Additive Computer Aided Manufacture and Curing SystemDeltamed GmbH · 2011
- This deviceK211101 E-TempEnvisiontec GmbH · 2021
- Descendant · cites it directly · 0 of its ownK243370 DentaTOOTHAsiga Pty, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK242559 Digital TempSprintray, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K070991 | Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102, VX59-4110… | Vita | 2007 | — |
| −1 | K102776 | Extra-Oral, Additive Computer Aided Manufacture and Curing System | Deltamed GmbH | 2011 | — |
| 0 (this device) | K211101 | E-Temp | Envisiontec GmbH | 2021 | — |
| +1 | K243370 | DentaTOOTH | Asiga Pty, Ltd. | 2025 | — |
| +1 | K242559 | Digital Temp | Sprintray, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K102776 | Extra-Oral, Additive Computer Aided Manufacture and Curing SystemSummary page 4…Classification 21 CFR 872.3770 Number | Name: Crown and Bridge, Temporary, Resin Product Code EBG Device Class II III. PREDICATE DEVICE Primary K102776, e-DENT Temporary Resin and Extra-Oral Curing System, Predicate Device DeltaMed GmbH Reference None D… | 2011 |
What descends from it? (2)
2 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 14 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K243370 (Asiga Pty, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K102776.
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. 2021, 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?
E-Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns and temporary bridges in dental laboratories. The material is an alternative to traditional restorative dental material. E-Temp is intended exclusively for professional dental work. Fabrication of dental applications with E-Temp requires a computer aided and manufacturing (CAD/CAM) system that includes the following components: digital dental files based on a digital impression or in case of artificial teeth for dental prostheses the digital dental files based on manufacturer’s data, a digital light processing (DLP) printer, and curing light equipment.
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/K211101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211101: E-Temp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211101
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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