510(k) · Cleared
ClearedFiber Disk and Block Permanent, Trinia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioloren S.R.L. · EBF Material, Tooth Shade, Resin
Cleared on Feb 21, 2013 after a 253-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Feb 21, 2013
- Review
- 253 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK121735 Fiber Disk and Block Permanent, TriniaBioloren S.R.L. · 2013
- Descendant · cites it directly · 4 of its ownK133608 TriniaBicon, LLC · 2014
- Descendant · 2 generations on · 3 of its ownK152113 BioHPP - breCAM.BioHPPBredent GmbH & Co. KG · 2016
- Descendant · 3 generations on · 0 of its ownK181484 Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med…Zirkonzahn Srl · 2018
- Descendant · 3 generations on · 0 of its ownK173124 PEEK BiosolutionMerz Dental GmbH · 2017
- Descendant · 3 generations on · 0 of its ownK170102 Pekkton IvoryCendres+Metaux SA · 2017
Most influential descendants
Showing 5 of 5 · See all- K133608TriniaBicon, LLC · 2014 · cites it directly4descendants
- K152113BioHPP - breCAM.BioHPPBredent GmbH & Co. KG · 2016 · 2 generations on3descendants
- K181484Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral TissueZirkonzahn Srl · 2018 · 3 generations on0descendants
- K173124PEEK BiosolutionMerz Dental GmbH · 2017 · 3 generations on0descendants
- K170102Pekkton IvoryCendres+Metaux SA · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K121735 | Fiber Disk and Block Permanent, Trinia | Bioloren S.R.L. | 2013 | — |
| +1 | K133608 | Trinia | Bicon, LLC | 2014 | — |
| +2 | K152113 | BioHPP - breCAM.BioHPP | Bredent GmbH & Co. KG | 2016 | — |
| +3 | K181484 | Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral… | Zirkonzahn Srl | 2018 | — |
| +3 | K173124 | PEEK Biosolution | Merz Dental GmbH | 2017 | — |
| +3 | K170102 | Pekkton Ivory | Cendres+Metaux SA | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133608 | Trinia | 2014 | 4 |
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, K133608 (Bicon, LLC, 2014) has gone furthest, with 4 descendants of its own.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
Fiber Disks and Blocks are milling blanks composed of a multi-directional interlacing of fiberglass and resin in several layers. They are intended to be used solely by dental technicians and dentists for making only copings, substructures or frameworks for permanent and transitional anterior or posterior crowns, bridgework and substructures that can be for either cemented or uncemented restorations e.g., telescopic restorations.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K121735 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121735: Fiber Disk and Block Permanent, Trinia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121735
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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