# K152113: BioHPP - breCAM.BioHPP

- Pathway: 510(k) (Traditional)
- Applicant: Bredent GmbH & Co. KG
- Decided: Jul 21, 2016 after 358 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: 3 generations back to K043504 (2005). 8 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133608: Trinia, Bicon, LLC (2014) Summary page 6.
- K132725: Juvora Dentqal Disc, Juvora (2014) Summary page 6.

## Most influential descendants
- K181484: Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue (2018), 0 descendants of its own
- K173124: PEEK Biosolution (2017), 0 descendants of its own
- K170102: Pekkton Ivory (2017), 0 descendants of its own

## Indications for use
BioHPP polymer is used for the fabrication of definitive crown and bridge frameworks with no more than 2 pontics and for definitive removable restorations. BioHPP can also be used for fully anatomical pressed bridge structures - with or without buccal composite veneering. • Fully anatomical crowns and bridges (max. 2 pontics) • Crown copings and bridge substructures for composite veneers (max. 2 pontics) • Telescopic primary and secondary crowns and frameworks • Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide breCAM.BioHPP is used for the fabrication of permanent restorations using CAD/CAM techniques. Fully anatomical crowns and bridges (max. 2 pontics and min. 13 mm² connector cross-section) Crown copings and bridge substructures for composite veneering (max. 2 pontics and min. 13 mm² connector cross-section)) Telescopic primary and secondary crowns and frameworks Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide. Reference is made to the instructions for use “BioHPP elegance prefab for SKY” to fabricate an individual abutment.

Source page: https://510kreport.com/device/K152113
Methodology: https://510kreport.com/methodology