510(k) · Cleared
ClearedDentca Base Premium, Dentca Base Hi-Impact
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentca, Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Nov 17, 2022 as substantially equivalent to K190043 (Dentsply Sirona, 2019) after a 316-day review. Its family tree reaches back 5 generations to 2001. 2 later devices descend from it.
- Decided
- Nov 17, 2022
- Review
- 316 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K011560 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK011560 Trubyte Denture Base Resin SystemDentsply Intl. · 2001
- 4 generations backK032892 Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003
- 3 generations backK143033 Dentca Denture BaseDentca, Inc. · 2015
- 2 generations backK162572 NextDent Denture, E-DentureVertex-Dental B.V. · 2017
- 1 generation backK190043 Halley resinDentsply Sirona · 2019
- This deviceK220042 Dentca Base Premium, Dentca Base Hi-ImpactDentca, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK260569 DB 4000 High Impact Denture BaseCarbon, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK260376 Denture BaseShandong Huge Dental Material Corporation · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | 2001 | — |
| −4 | K032892 | Modification to Trubyte Denture Base Resin System | Dentsply Intl. | 2003 | — |
| −3 | K143033 | Dentca Denture Base | Dentca, Inc. | 2015 | — |
| −2 | K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | 2017 | — |
| −1 | K190043 | Halley resin | Dentsply Sirona | 2019 | — |
| 0 (this device) | K220042 | Dentca Base Premium, Dentca Base Hi-Impact | Dentca, Inc. | 2022 | — |
| +1 | K260569 | DB 4000 High Impact Denture Base | Carbon, Inc. | 2026 | — |
| +1 | K260376 | Denture Base | Shandong Huge Dental Material Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K190043 | Halley resinSummary page 4…latory Class: II Review Panel: Dental Predicate Device The following predicate is a legally marketed, post-amendment device: 510(k) Number: K190043 Clearance Date: April 24, 2019 Trade Name: Halley Resin Actual Trade Name: Lucitone Digital Print Ma… | 2019 |
| † | K160244 | VARIOunite | 2016 |
What descends from it? (2)
2 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 21 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K260569 (Carbon, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K190043.
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. 2022, 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?
DENTCA Base Resin is a light-curable resin indicated for the fabrication and repair of removable denture bases in dental laboratories, including full and partial dentures as well as immediate dentures, and baseplates. DENTCA Base Resin can also be used for the fabrication of try-in dentures for the evaluation before fabricating the final dentures.
Fabrication of these prostheses with DENTCA Base Resin requires a digital denture file, additive printer, and curing light equipment.
DENTCA Base Resin can be utilized as an aid in bonding the denture teeth onto denture base.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220042: Dentca Base Premium, Dentca Base Hi-Impact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220042
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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