# K170102: Pekkton Ivory

- Pathway: 510(k) (Traditional)
- Applicant: Cendres+Metaux SA
- Decided: Nov 13, 2017 after 306 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
• Definitive supported and veneered crowns and bridges with maximum two pontics. Can be veneered with bonded press crowns, with composites or prefabricated acrylic teeth and veneers. • Definitive supported, veneered single crowns and bridges with maximum one pontic on natural teeth. • Removable restoration such as secondary structures on bars and telescopic crowns, transversal connectors, occlusal splints and denture bases.

Source page: https://510kreport.com/device/K170102
Methodology: https://510kreport.com/methodology