510(k) · Cleared
ClearedTCS Unbreakable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermoplastic Comfort Systems, Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Jul 20, 2006 after a 262-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 21 later devices descend from it.
- Decided
- Jul 20, 2006
- Review
- 262 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 8 citing it directly.
- This deviceK053060 TCS UnbreakableThermoplastic Comfort Systems, Inc. · 2006
- Descendant · cites it directly · 10 of its ownK123220 Vertex Thermosens RigidVertex-Dental B.V. · 2013
- Descendant · 2 generations on · 8 of its ownK132725 Juvora Dentqal DiscJuvora · 2014
- Descendant · cites it directly · 3 of its ownK250617 Apex FlexSprintray, Inc. · 2025
- Descendant · 3 generations on · 3 of its ownK160918 JUVORA Dental Disc, Ceramill PEEK by JUVORAJuvora · 2017
- Descendant · 3 generations on · 3 of its ownK152113 BioHPP - breCAM.BioHPPBredent GmbH & Co. KG · 2016
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K123220Vertex Thermosens RigidVertex-Dental B.V. · 2013 · cites it directly10descendants
- K132725Juvora Dentqal DiscJuvora · 2014 · 2 generations on8descendants
- K250617Apex FlexSprintray, Inc. · 2025 · cites it directly3descendants
- K160918JUVORA Dental Disc, Ceramill PEEK by JUVORAJuvora · 2017 · 3 generations on3descendants
- K152113BioHPP - breCAM.BioHPPBredent GmbH & Co. KG · 2016 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053060 | TCS Unbreakable | Thermoplastic Comfort Systems, Inc. | 2006 | — |
| +1 | K123220 | Vertex Thermosens Rigid | Vertex-Dental B.V. | 2013 | — |
| +2 | K132725 | Juvora Dentqal Disc | Juvora | 2014 | — |
| +1 | K250617 | Apex Flex | Sprintray, Inc. | 2025 | — |
| +3 | K160918 | JUVORA Dental Disc, Ceramill PEEK by JUVORA | Juvora | 2017 | — |
| +3 | K152113 | BioHPP - breCAM.BioHPP | Bredent GmbH & Co. KG | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (21)
See all 218 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, K123220 (Vertex-Dental B.V., 2013) has gone furthest, with 10 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 | — |
What is it indicated for?
TCS® Unbreakable is a break resistant material used in the fabrication and repair of base plates for removeable dental prosthetic appliances where superior flexibility and patient comfort for the lifetime of the prosthetic are significant concerns. This includes, but not to be limited to, full and partial dentures, orthodontic devices, occlusal splints, and night guards.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K053060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053060: TCS Unbreakable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053060
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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