# K181484: Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue

- Pathway: 510(k) (Traditional)
- Applicant: Zirkonzahn Srl
- Decided: Jun 18, 2018 after 13 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K043504 (2005). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152113: BioHPP - breCAM.BioHPP, Bredent GmbH & Co. KG (2016) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K181484
Methodology: https://510kreport.com/methodology