510(k) · Cleared
ClearedRibbond - Triaxial
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 Jan 25, 2002 as substantially equivalent to K913040 (Ribbond, Inc., 1991) after a 63-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- Jan 25, 2002
- Review
- 63 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913040 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK913040 Ribbond (TM)Ribbond, Inc. · 1991
- This deviceK013881 Ribbond - TriaxialRibbond, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK034024 Tescera Fiber Bundles, Fiber Mesh and Fiber CylindersBisco, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK031070 Carbon Fiber Bridge, Model 28757Nobel Biocare AB · 2003
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 |
|---|---|---|---|---|---|
| −1 | K913040 | Ribbond (TM) | Ribbond, Inc. | 1991 | — |
| 0 (this device) | K013881 | Ribbond - Triaxial | Ribbond, Inc. | 2002 | — |
| +1 | K034024 | Tescera Fiber Bundles, Fiber Mesh and Fiber Cylinders | Bisco, Inc. | 2004 | — |
| +1 | K031070 | Carbon Fiber Bridge, Model 28757 | Nobel Biocare AB | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K913040 | Ribbond (TM)Summary page 1…d and removable bridges. To reinforce splints used to immobilize teeth. Substantial Equivalency: Ribbond-Triaxial is substantially equivalent to Ribbond, cleared under K913040 dated October 7, 1991. Description of new design characteristics Ribbond-Triaxial is made using a triaxial braid. Ribbond is m… | 1991 |
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?
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 | — |
What is it indicated for?
Ribbond-Triaxial is intended to provide reinforcement to acrylic or composite resins used for dental restorations. It is used by dentists and dental technicians. It can be used for the following applications:
As reinforcement in manufacturing and/or repairing full or partial-dentures as well as overdentures, night-guards and orthodontic appliances.
To repair and reinforce resin or composite prostheses including temporary and permanent bonded and removable bridges.
To reinforce splints used to immobilize teeth.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013881: Ribbond - Triaxial.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013881
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026