510(k) · Cleared
ClearedVertex Rapid Simplified
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 Dec 3, 2010 as substantially equivalent to K913655 (Ivoclar North America, Inc., 1991) and 1 other predicate after an 80-day review. Its family tree reaches back 2 generations to 1990. 20 later devices descend from it.
- Decided
- Dec 3, 2010
- Review
- 80 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K901789 (1990). 3 ancestors in all. 20 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK901789 Paladon (R) 65Kulzer, Inc. · 1990
- 1 generation backK081884 Major.Base 20Major Prodotti Dentari S.P.A. · 2008
- This deviceK102654 Vertex Rapid SimplifiedVertex-Dental B.V. · 2010
- Descendant · cites it directly · 18 of its ownK130076 Promolux, Promolux HI, Weropress, Premeco PCSMerz Dental GmbH · 2013
- Descendant · 2 generations on · 17 of its ownK140758 M-PM-Disc (Pink)Merz Dental GmbH · 2014
- Descendant · 3 generations on · 14 of its ownK151142 Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling…Wieland Dental + Technik GmbH & Co. KG · 2015
- Descendant · 4 generations on · 7 of its ownK210977 E-Dent 1000Envisiontec GmbH · 2021
- Descendant · 5 generations on · 4 of its ownK222623 Digital CrownSprintray, Inc. · 2022
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K130076Promolux, Promolux HI, Weropress, Premeco PCSMerz Dental GmbH · 2013 · cites it directly18descendants
- K140758M-PM-Disc (Pink)Merz Dental GmbH · 2014 · 2 generations on17descendants
- K151142Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling LiquidWieland Dental + Technik GmbH & Co. KG · 2015 · 3 generations on14descendants
- K210977E-Dent 1000Envisiontec GmbH · 2021 · 4 generations on7descendants
- K222623Digital CrownSprintray, Inc. · 2022 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901789 | Paladon (R) 65 | Kulzer, Inc. | 1990 | — |
| −1 | K081884 | Major.Base 20 | Major Prodotti Dentari S.P.A. | 2008 | — |
| 0 (this device) | K102654 | Vertex Rapid Simplified | Vertex-Dental B.V. | 2010 | — |
| +1 | K130076 | Promolux, Promolux HI, Weropress, Premeco PCS | Merz Dental GmbH | 2013 | — |
| +2 | K140758 | M-PM-Disc (Pink) | Merz Dental GmbH | 2014 | — |
| +3 | K151142 | Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling Liquid | Wieland Dental + Technik GmbH & Co. KG | 2015 | — |
| +4 | K210977 | E-Dent 1000 | Envisiontec GmbH | 2021 | — |
| +5 | K222623 | Digital Crown | Sprintray, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K913655 | Probase Hot and Probase ColdSummary page 1…ial Classification Name, resin, denture, relining, repairing, rebasing Number & 872,3760 Product Code: EBl Predicate Devices: Probase Hot (K913655), MajorBase 20 (K081884) Device Description Device Descripition: The Vertex hot-curing denture base material is a an… | 1991 |
| * | K081884 | Major.Base 20Summary page 1…, resin, denture, relining, repairing, rebasing Number & 872,3760 Product Code: EBl Predicate Devices: Probase Hot (K913655), MajorBase 20 (K081884) Device Description Device Descripition: The Vertex hot-curing denture base material is a and of Sate… | 2008 |
What descends from it? (20)
See all 202 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 20 years and passes through 3 companies; a new generation was cleared every 18.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K130076 (Merz Dental GmbH, 2013) has gone furthest, with 18 descendants of its own.
- 3 other devices also cite its predicate K913655.
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. 2010, 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?
The Vertex Rapid Simplified is indicated for:
1 Fabrication of full dentures
2. Fabrication of partial dentures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102654: Vertex Rapid Simplified.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102654
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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