510(k) · Cleared
ClearedTender Fiber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micerium S.P.A. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Jan 12, 2007 as substantially equivalent to K011788 (Stick Tech, Ltd., 2001) and 4 other predicates after an 86-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Jan 12, 2007
- Review
- 86 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K003333 (2001). 5 ancestors in all, the oldest K913040 (1991). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003333 | STICK | Stick Tech, Ltd. | 2001 | — |
| −2 | K011788 | Everstick | Stick Tech, Ltd. | 2001 | — |
| −1 | K021126 | Everstick Ortho | Stick Tech, Ltd. | 2002 | — |
| 0 (this device) | K063170 | Tender Fiber | Micerium S.P.A. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2003 | 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? (5)
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 |
|---|---|---|---|
| * | K011788 | Everstick | 2001 |
| * | K030072 | Everstick PerioSummary page 2…e substantially eq'aivalent to: - Everstick by Stick Tech Ltd., 51$) (k) no.: KOl 1788 - Everstick Perio by Stick Tech Lid., 510 (k) no.: K030072 - Everstick Ortho by Stick Tech Llid., 510 (k) no.: K021126 - Stick by Stick Tech Ltd., 510(k) no… | 2003 |
| * | K021126 | Everstick OrthoSummary page 2…d., 51$) (k) no.: KOl 1788 - Everstick Perio by Stick Tech Lid., 510 (k) no.: K030072 - Everstick Ortho by Stick Tech Llid., 510 (k) no.: K021126 - Stick by Stick Tech Ltd., 510(k) no.: K003333 - Ribbond (TM) by Ribbond Inc, I10(k) no.: K91304… | 2002 |
| * | K003333 | STICKSummary page 2…Stick Tech Lid., 510 (k) no.: K030072 - Everstick Ortho by Stick Tech Llid., 510 (k) no.: K021126 - Stick by Stick Tech Ltd., 510(k) no.: K003333 - Ribbond (TM) by Ribbond Inc, I10(k) no.: K913040 1. These products have the same intended use… | 2001 |
| * | K913040 | Ribbond (TM)Summary page 2…rtho by Stick Tech Llid., 510 (k) no.: K021126 - Stick by Stick Tech Ltd., 510(k) no.: K003333 - Ribbond (TM) by Ribbond Inc, I10(k) no.: K913040 1. These products have the same intended use as predicate devices. 2. Technological characteris… | 1991 |
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 6 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- None of the 5 ancestors has a recall.
- 7 other devices also cite its predicate K011788.
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. 2007, 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?
Tender fiber is a semi-manufactured product made of fibers used to
reinforce composite and acrylic prosthodontic appliances and to repair or reinforce denture and
orthodontic appliances. It can be used as well to immobilize teeth for periodontic or orthodontic
treatments.
These products are for use only by trained and experienced dentists and dental technicians and
have become well-known in this area of dentistry, therefore they do not require prescription (Per
21 CFR 801 Subpart D)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063170: Tender Fiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063170
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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