510(k) · Cleared
ClearedTecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zirkonzahn Srl · EBF Material, Tooth Shade, Resin
Cleared on Jun 18, 2018 as substantially equivalent to K152113 (Bredent GmbH & Co. KG, 2016) after a 13-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Jun 18, 2018
- Review
- 13 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K043504 (2005). 9 ancestors in all, the oldest K992956 (1999). No later device cites it as a predicate yet.
- Root · 4 generations backK043504 PalaimpactHeraeus Kulzer, Inc. · 2005
- 3 generations backK111832 Paladon Ultra Powder (Pink), Paladon Ultra LiquidHeraeus Kulzer, LLC · 2011
- 2 generations backK132725 Juvora Dentqal DiscJuvora · 2014
- 1 generation backK152113 BioHPP - breCAM.BioHPPBredent GmbH & Co. KG · 2016
- This deviceK181484 Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med…Zirkonzahn Srl · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K043504 | Palaimpact | Heraeus Kulzer, Inc. | 2005 | — |
| −3 | K111832 | Paladon Ultra Powder (Pink), Paladon Ultra Liquid | Heraeus Kulzer, LLC | 2011 | — |
| −2 | K132725 | Juvora Dentqal Disc | Juvora | 2014 | — |
| −1 | K152113 | BioHPP - breCAM.BioHPP | Bredent GmbH & Co. KG | 2016 | — |
| 0 (this device) | K181484 | Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral… | Zirkonzahn Srl | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K152113 | BioHPP - breCAM.BioHPPSummary page 4…edicate Device Already cleared device selected to demonstrate substantial equivalence: Company: Bredent GmbH & Co. KG Predicate Device Name: breCAM.BioHPP 510(k) Number: K152113 Product Code: EBF Subsequent Product Code: EBI Class: II Section 5… | 2016 |
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 13 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 9 ancestors has a recall.
- 2 other devices also cite its predicate K152113.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
TECNO MED MINERAL, TECNO MED MINERAL DENTINE and TECNO MED MINERAL TISSUE are used to
create reduced crowns and bridges (max. 2 pontics and min. 13 mm² connection cross-section), telescopic primary
crowns, copings as well as frameworks for composite veneered bridges. The width of the bridge must not exceed two
pontics for reasons of stability.
TECNO MED is designed for the manufacturing of frictional elements on telescopic restorations or attachments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181484: Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181484
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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