510(k) · Cleared
ClearedExtra-Oral, Additive Computer Aided Manufacture and Curing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deltamed GmbH · EBG Crown And Bridge, Temporary, Resin
Cleared on Feb 18, 2011 as substantially equivalent to K070991 (Vita, 2007) after a 147-day review. Its family tree reaches back 1 generation to 2007. 12 later devices descend from it.
- Decided
- Feb 18, 2011
- Review
- 147 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070991 (2007). 12 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK070991 Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102…Vita · 2007
- This deviceK102776 Extra-Oral, Additive Computer Aided Manufacture and Curing SystemDeltamed GmbH · 2011
- Descendant · cites it directly · 4 of its ownK180657 Resin for Temporary Crown & BridgeDentis Co., Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK211101 E-TempEnvisiontec GmbH · 2021
- Descendant · cites it directly · 1 of its ownK201827 GR-17 Resin SystemPro3Dure Medical GmbH · 2020
- Descendant · 2 generations on · 1 of its ownK200273 FREEPRINT tempDetax GmbH & Co. KG · 2020
- Descendant · cites it directly · 1 of its ownK200039 P pro Crown & BridgeDeltamed GmbH · 2020
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K180657Resin for Temporary Crown & BridgeDentis Co., Ltd. · 2018 · cites it directly4descendants
- K211101E-TempEnvisiontec GmbH · 2021 · cites it directly2descendants
- K201827GR-17 Resin SystemPro3Dure Medical GmbH · 2020 · cites it directly1descendant
- K200273FREEPRINT tempDetax GmbH & Co. KG · 2020 · 2 generations on1descendant
- K200039P pro Crown & BridgeDeltamed GmbH · 2020 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070991 | Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102, VX59-4110… | Vita | 2007 | — |
| 0 (this device) | K102776 | Extra-Oral, Additive Computer Aided Manufacture and Curing System | Deltamed GmbH | 2011 | — |
| +1 | K180657 | Resin for Temporary Crown & Bridge | Dentis Co., Ltd. | 2018 | — |
| +1 | K211101 | E-Temp | Envisiontec GmbH | 2021 | — |
| +1 | K201827 | GR-17 Resin System | Pro3Dure Medical GmbH | 2020 | — |
| +2 | K200273 | FREEPRINT temp | Detax GmbH & Co. KG | 2020 | — |
| +1 | K200039 | P pro Crown & Bridge | Deltamed GmbH | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K070991 | Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202…Summary page 1…E OR PROPRIETARY NAME: e-DENT TEMPORARY RESIN and EXTRA-ORAL CURING SYSTEM CLASSIFICATION NAME: Temporary Crown and Bridge Resin, per 21 CFR 872.3770 PREDICATE DEVICE: K070991, VITA CAD TEMP, Temporary Crown and Bridge Resin, per 21 CFR 872.3770 This summary includes only information that is also covere… | 2007 |
What descends from it? (12)
See all 125 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. 2011, 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-DENT TEMPORARY resin is indicated for the fabrication of
temporary dental restorations in conjunction with extra-oral 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/K102776 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102776: Extra-Oral, Additive Computer Aided Manufacture and Curing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102776
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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