510(k) · Cleared
ClearedNextDent Jet Denture Base; NextDent Jet Denture Teeth
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vertex-Dental B.V. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Sep 4, 2024 as substantially equivalent to K231388 (Vertex-Dental B.V., 2023) and 1 other predicate after a 138-day review. Its family tree reaches back 9 generations to 2004.
- Decided
- Sep 4, 2024
- Review
- 138 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K042819 (2004). 23 ancestors in all, the oldest K920425 (1992). No later device cites it as a predicate yet.
- Root · 9 generations backK042819 Tetric EvoceramIvoclar Vivadent, Inc. · 2004
- 5 generations between
- 3 generations backK201668 VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020
- 2 generations backK202846 Tera HarzGraphy, Inc. · 2021
- 1 generation backK213343 Saremco Print CROWNTECSaremco Dental AG · 2022
- This deviceK241071 NextDent Jet Denture Base; NextDent Jet Denture TeethVertex-Dental B.V. · 2024
Show all 9 generations
- Root · 9 generations backK042819 Tetric EvoceramIvoclar Vivadent, Inc. · 2004
- 8 generations backK091388 GCUC-505GC America, Inc. · 2009
- 7 generations backK123631 MFP-051GC America, Inc. · 2013
- 6 generations backK133824 CerasmartGC America, Inc. · 2014
- 5 generations backK160425 CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc. · 2016
- 4 generations backK162537 CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016
- 3 generations backK201668 VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020
- 2 generations backK202846 Tera HarzGraphy, Inc. · 2021
- 1 generation backK213343 Saremco Print CROWNTECSaremco Dental AG · 2022
- This deviceK241071 NextDent Jet Denture Base; NextDent Jet Denture TeethVertex-Dental B.V. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K042819 | Tetric Evoceram | Ivoclar Vivadent, Inc. | 2004 | — |
| −8 | K091388 | GCUC-505 | GC America, Inc. | 2009 | — |
| −7 | K123631 | MFP-051 | GC America, Inc. | 2013 | — |
| −6 | K133824 | Cerasmart | GC America, Inc. | 2014 | — |
| −5 | K160425 | CAD/CAMouflage Milling Bock | Prismatik Dentalcraft, Inc. | 2016 | — |
| −4 | K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. | 2016 | — |
| −3 | K201668 | VarseoSmile Crown plus | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2020 | — |
| −2 | K202846 | Tera Harz | Graphy, Inc. | 2021 | — |
| −1 | K213343 | Saremco Print CROWNTEC | Saremco Dental AG | 2022 | — |
| 0 (this device) | K241071 | NextDent Jet Denture Base; NextDent Jet Denture Teeth | Vertex-Dental B.V. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2008 | 3 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 EBI? 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 EBI device
- #1 K250617 Apex Flexscore 18.3 · 1 generation · 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 |
|---|---|---|---|
| * | K231388 | NextDent BaseSummary page 5…ass 2 Classification 21 CFR 872.3760 21 CFR 872.3770 Regulation 21 CFR 872.3590 III. PREDICATE NextDent Base, K231388 DEVICE(s) Saremco Print CROWNTEC, K213343 IV. DEVICE DESCRIPTION Device Identification: Light-Curable Resin D… | 2023 |
| * | K213343 | Saremco Print CROWNTECSummary page 5…21 CFR 872.3770 Regulation 21 CFR 872.3590 III. PREDICATE NextDent Base, K231388 DEVICE(s) Saremco Print CROWNTEC, K213343 IV. DEVICE DESCRIPTION Device Identification: Light-Curable Resin Device Characteristics: NextDent Jet Denture resins are pre… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 23 ancestors has a recall of any class.
How does its category compare?
All EBI devicesEBI Resin, Denture, Relining, Repairing, Rebasing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · EBI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBI
79in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBI
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBI
34in 2025
MAUDE reports naming product code EBI, 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 | 10 | 53 | 0 | 7 |
| 2008 | 6 | 124 | 0 | 2 |
| 2009 | 3 | 234 | 0 | 5 |
| 2010 | 4 | 95 | 0 | 4 |
| 2011 | 11 | 113 | 0 | 6 |
| 2012 | 3 | 85 | 0 | 9 |
| 2013 | 5 | 135 | 0 | 5 |
| 2014 | 5 | 102 | 0 | 9 |
| 2015 | 9 | 106 | 0 | 8 |
| 2016 | 7 | 147 | 0 | 9 |
| 2017 | 8 | 196 | 0 | 2 |
| 2018 | 5 | 158 | 2 | 2 |
| 2019 | 4 | 127 | 0 | 10 |
| 2020 | 6 | 283 | 0 | 8 |
| 2021 | 4 | 99 | 0 | 25 |
| 2022 | 11 | 154 | 2 | 2 |
| 2023 | 11 | 96 | 0 | 13 |
| 2024 | 9 | 90 | 0 | 1 |
| 2025 | 11 | 79 | 0 | 34 |
| 2026 | 7 | 87 | 0 | — |
What is it indicated for?
NextDent Jet Denture Base is a light curing resin intended for 30 printing of a full or partial denture base to form a denture. The product, when used in combination with NextDent Jet Denture Teeth can be used for 30 printing a removable full or partial denture.
For dental professional use only.
NextDent Jet Denture Teeth is a light curing resin intended for the 30 printing of artificial teeth to form a denture, temporary crowns or bridges. The product, when used in combination with NextDent Jet Denture Base can be used for 30 printing a removeable full or partial denture.
For dental professional use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241071 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241071: NextDent Jet Denture Base; NextDent Jet Denture Teeth.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241071
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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