510(k) · Cleared
ClearedRibbond (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ribbond, Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Oct 7, 1991 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.
- Decided
- Oct 7, 1991
- Review
- 90 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 5 citing it directly.
- This deviceK913040 Ribbond (TM)Ribbond, Inc. · 1991
- Descendant · cites it directly · 2 of its ownK013881 Ribbond - TriaxialRibbond, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK030820 Everstick PostStick Tech, Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK063170 Tender FiberMicerium S.P.A. · 2007
- Descendant · cites it directly · 0 of its ownK061735 Infibra, Model 1200Global Dental Products, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK060075 Fiber-Metal PostForemost Dental, LLC · 2006
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K013881Ribbond - TriaxialRibbond, Inc. · 2002 · cites it directly2descendants
- K030820Everstick PostStick Tech, Ltd. · 2003 · cites it directly1descendant
- K063170Tender FiberMicerium S.P.A. · 2007 · cites it directly0descendants
- K061735Infibra, Model 1200Global Dental Products, Inc. · 2006 · cites it directly0descendants
- K060075Fiber-Metal PostForemost Dental, LLC · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913040 | Ribbond (TM) | Ribbond, Inc. | 1991 | — |
| +1 | K013881 | Ribbond - Triaxial | Ribbond, Inc. | 2002 | — |
| +1 | K030820 | Everstick Post | Stick Tech, Ltd. | 2003 | — |
| +1 | K063170 | Tender Fiber | Micerium S.P.A. | 2007 | — |
| +1 | K061735 | Infibra, Model 1200 | Global Dental Products, Inc. | 2006 | — |
| +2 | K060075 | Fiber-Metal Post | Foremost Dental, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (8)
5 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?
- Of its descendants, K013881 (Ribbond, Inc., 2002) has gone furthest, with 2 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/K913040 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913040: Ribbond (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913040
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026