510(k) · Cleared
ClearedE-Dent 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Envisiontec GmbH · EBF Material, Tooth Shade, Resin
Cleared on May 25, 2021 as substantially equivalent to K201668 (Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG, 2020) and 1 other predicate after a 54-day review. Its family tree reaches back 7 generations to 2004. 7 later devices descend from it.
- Decided
- May 25, 2021
- Review
- 54 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K042819 (2004). 29 ancestors in all, the oldest K901789 (1990). 7 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK042819 Tetric EvoceramIvoclar Vivadent, Inc. · 2004
- 6 generations backK091388 GCUC-505GC America, Inc. · 2009
- 5 generations backK123631 MFP-051GC America, Inc. · 2013
- 4 generations backK133824 CerasmartGC America, Inc. · 2014
- 3 generations backK160425 CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc. · 2016
- 2 generations backK162537 CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016
- 1 generation backK201668 VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020
- This deviceK210977 E-Dent 1000Envisiontec GmbH · 2021
- Descendant · cites it directly · 4 of its ownK222623 Digital CrownSprintray, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK242277 Crown HTSprintray, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK220771 Stratasys TrueDentStratasys, Ltd. · 2022 · Recalled
- Descendant · 3 generations on · 0 of its ownK261246 SRGC-06GC America, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260152 Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT…Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K222623Digital CrownSprintray, Inc. · 2022 · cites it directly4descendants
- K242277Crown HTSprintray, Inc. · 2024 · 2 generations on1descendant
- K220771Stratasys TrueDentStratasys, Ltd. · 2022 · cites it directly1descendant
- K261246SRGC-06GC America, Inc. · 2026 · 3 generations on0descendants
- K260152Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K042819 | Tetric Evoceram | Ivoclar Vivadent, Inc. | 2004 | — |
| −6 | K091388 | GCUC-505 | GC America, Inc. | 2009 | — |
| −5 | K123631 | MFP-051 | GC America, Inc. | 2013 | — |
| −4 | K133824 | Cerasmart | GC America, Inc. | 2014 | — |
| −3 | K160425 | CAD/CAMouflage Milling Bock | Prismatik Dentalcraft, Inc. | 2016 | — |
| −2 | K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. | 2016 | — |
| −1 | K201668 | VarseoSmile Crown plus | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2020 | — |
| 0 (this device) | K210977 | E-Dent 1000 | Envisiontec GmbH | 2021 | — |
| +1 | K222623 | Digital Crown | Sprintray, Inc. | 2022 | — |
| +2 | K242277 | Crown HT | Sprintray, Inc. | 2024 | — |
| +1 | K220771 | Stratasys TrueDent | Stratasys, Ltd. | 2022 | 5 |
| +3 | K261246 | SRGC-06 | GC America, Inc. | 2026 | — |
| +2 | K260152 | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 3 | 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 EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K201668 | VarseoSmile Crown plusSummary page 4…ELM II II II, 510(k)-Exempt III. PREDICATE DEVICE Predicate Devices Primary Predicate K201668, VarseoSmile Crown Plus, BEGO Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG (EBF product code)… | 2020 |
| * | K151142 | Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling LiquidSummary page 4…y Predicate K201668, VarseoSmile Crown Plus, BEGO Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG (EBF product code) Secondary K151142, IvoBase CAD for Zenotec, IvoBase CAD Bond and Predicate Modelling Liquid, Ivoclar Vivadent, Inc. (EBI product code… | 2015 |
| † | K102776 | Extra-Oral, Additive Computer Aided Manufacture and Curing System | 2011 |
What descends from it? (7)
3 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 17 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 29 ancestors has a recall of any class.
- Of its descendants, K222623 (Sprintray, Inc., 2022) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K201668.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
E-Dent 1000 is a light-curable resin indicated for the fabrication of: » individual and fixed permanent full single crowns, permanent partial crowns in front and posterior area, » individual and fixed single veneers, » artificial teeth for dental prostheses, which are used for removable permanent full dentures, » individual and removable monolithic full and partial dentures in dental laboratories. The material is an alternative to traditional restorative…
Read the full statement (133 words)
E-Dent 1000 is a light-curable resin indicated for the fabrication of:
» individual and fixed permanent full single crowns, permanent partial crowns in front and posterior area,
» individual and fixed single veneers,
» artificial teeth for dental prostheses, which are used for removable permanent full dentures,
» individual and removable monolithic full and partial dentures
in dental laboratories. The material is an alternative to traditional restorative dental material. E-Dent 1000 is intended exclusively for professional dental work. Fabrication of dental applications with E-Dent 1000 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/K210977 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210977: E-Dent 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210977
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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