510(k) · Cleared
ClearedTrinia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bicon, LLC · EBF Material, Tooth Shade, Resin
Cleared on Mar 14, 2014 as substantially equivalent to K121735 (Bioloren S.R.L., 2013) after a 109-day review. Its family tree reaches back 1 generation to 2013. 4 later devices descend from it.
- Decided
- Mar 14, 2014
- Review
- 109 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K121735 (2013). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK121735 Fiber Disk and Block Permanent, TriniaBioloren S.R.L. · 2013
- This deviceK133608 TriniaBicon, LLC · 2014
- Descendant · cites it directly · 3 of its ownK152113 BioHPP - breCAM.BioHPPBredent GmbH & Co. KG · 2016
- Descendant · 2 generations on · 0 of its ownK181484 Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med…Zirkonzahn Srl · 2018
- Descendant · 2 generations on · 0 of its ownK173124 PEEK BiosolutionMerz Dental GmbH · 2017
- Descendant · 2 generations on · 0 of its ownK170102 Pekkton IvoryCendres+Metaux SA · 2017
Most influential descendants
Showing 4 of 4 · See all- K152113BioHPP - breCAM.BioHPPBredent GmbH & Co. KG · 2016 · cites it directly3descendants
- K181484Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral TissueZirkonzahn Srl · 2018 · 2 generations on0descendants
- K173124PEEK BiosolutionMerz Dental GmbH · 2017 · 2 generations on0descendants
- K170102Pekkton IvoryCendres+Metaux SA · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K121735 | Fiber Disk and Block Permanent, Trinia | Bioloren S.R.L. | 2013 | — |
| 0 (this device) | K133608 | Trinia | Bicon, LLC | 2014 | — |
| +1 | K152113 | BioHPP - breCAM.BioHPP | Bredent GmbH & Co. KG | 2016 | — |
| +2 | K181484 | Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral… | Zirkonzahn Srl | 2018 | — |
| +2 | K173124 | PEEK Biosolution | Merz Dental GmbH | 2017 | — |
| +2 | K170102 | Pekkton Ivory | Cendres+Metaux SA | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 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 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? (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 |
|---|---|---|---|
| * | K121735 | Fiber Disk and Block Permanent, TriniaSummary page 1…--T-t lae [Device Name IManufacturer 510(k) # Dt lae Fiber Disk and Block Permanent IBioloren S.r.l. K 121735 1Februar- 2 1. 2013 Description of the device [21 CFR 807.92 (a)(4)] TRINIA is a fiber machining disk block. It is made of layer… | 2013 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152113 | BioHPP - breCAM.BioHPP | 2016 | 3 |
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?
- Its one ancestor has no recall.
- Of its descendants, K152113 (Bredent GmbH & Co. KG, 2016) has gone furthest, with 3 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. 2014, 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 (TRINIA) are milling blanks composed of a multi-directional interlacing of fiberglass and resin inseveral layers. They are intended to be used solely by dental technicians and dentists for making copings, substructures, removable dentures, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K133608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133608: Trinia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133608
Report an extraction error
Are you the manufacturer?
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