510(k) · Cleared
ClearedDenture Relining, Repair/Rebasing Resin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Jun 30, 1983 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.
- Decided
- Jun 30, 1983
- Review
- 38 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK831647 Denture Relining, Repair/Rebasing ResinDentsply Intl. · 1983
- Descendant · cites it directly · 0 of its ownK052780 Dentaplast Hot, Model 16-XXXBredent-Products For the Dental Technician Laborat · 2005
Most influential descendants
Showing 1 of 1 · See all- K052780Dentaplast Hot, Model 16-XXXBredent-Products For the Dental Technician Laborat · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K831647 | Denture Relining, Repair/Rebasing Resin | Dentsply Intl. | 1983 | — |
| +1 | K052780 | Dentaplast Hot, Model 16-XXX | Bredent-Products For the Dental Technician Laborat | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052780 | Dentaplast Hot, Model 16-XXX | 2005 | 0 |
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?
- Of its descendants, K052780 (Bredent-Products For the Dental Technician Laborat, 2005) has gone furthest, with 0 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K831647 · printed Nov 4, 2026
Cite this page
510(k) Report. “K831647: Denture Relining, Repair/Rebasing Resin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K831647
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026