510(k) · Cleared
ClearedDB 4000 High Impact Denture Base
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carbon, Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Jun 2, 2026 as substantially equivalent to K220042 (Dentca, Inc., 2022) and 1 other predicate after a 103-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Jun 2, 2026
- Review
- 103 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K011560 (2001). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK011560 Trubyte Denture Base Resin SystemDentsply Intl. · 2001
- 5 generations backK032892 Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003
- 4 generations backK143033 Dentca Denture BaseDentca, Inc. · 2015
- 3 generations backK162572 NextDent Denture, E-DentureVertex-Dental B.V. · 2017
- 2 generations backK190043 Halley resinDentsply Sirona · 2019
- 1 generation backK220042 Dentca Base Premium, Dentca Base Hi-ImpactDentca, Inc. · 2022
- This deviceK260569 DB 4000 High Impact Denture BaseCarbon, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | 2001 | — |
| −5 | K032892 | Modification to Trubyte Denture Base Resin System | Dentsply Intl. | 2003 | — |
| −4 | K143033 | Dentca Denture Base | Dentca, Inc. | 2015 | — |
| −3 | K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | 2017 | — |
| −2 | K190043 | Halley resin | Dentsply Sirona | 2019 | — |
| −1 | K220042 | Dentca Base Premium, Dentca Base Hi-Impact | Dentca, Inc. | 2022 | — |
| 0 (this device) | K260569 | DB 4000 High Impact Denture Base | Carbon, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K220042 | Dentca Base Premium, Dentca Base Hi-ImpactSummary page 5…Product Code: EBI Regulatory Class: II PREDICATE DEVICE The following predicate and reference devices are legally marketed, post-amendment devices: Predicate Number: K220042 Predicate Name: DENTCA Base Resin Predicate Product Code: EBI Reference Number: K220979 Reference Name: SprintRay Dental Base Re… | 2022 |
| * | K220979 | SprintRay Denture BaseSummary page 5…ference devices are legally marketed, post-amendment devices: Predicate Number: K220042 Predicate Name: DENTCA Base Resin Predicate Product Code: EBI Reference Number: K220979 Reference Name: SprintRay Dental Base Reference Product Code: EBI DEVICE DESCRIPTION DB 4000 High Impact Denture Base is a photo… | 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 25 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K220042.
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. 2026, 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?
DB 4000 High Impact Denture Base is indicated for the fabrication of dental devices for fully edentulous patients using
additive manufacturing on 3D printers. This includes the fabrication of full removable dentures, overdentures, try-ins and
temporary dentures. Fabrication of dental devices using DB 4000 High Impact Denture Base requires a digital denture
file, digital light synthesis (DLP) 3D printer and curing light equipment. DB 4000 High Impact Denture Base can be
utilized as an aid in bonding the denture teeth to the denture base.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260569 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260569: DB 4000 High Impact Denture Base.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260569
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026