# K123638: Pekkton Ivory

- Pathway: 510(k) (Traditional)
- Applicant: Cendres & Metaux SA
- Decided: Feb 21, 2013 after 87 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K894844 (1990). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093027: Straumann RC Temporary Abutments, Straumann USA (2010) Summary page 1.
- K093708: Telio Cad, Ivoclar Vivadent, Inc. (2010) Summary page 1.
- K093473: KMD-MARK1 Tissue Marker, Kent Medical Devices, Inc. (2010) Summary page 1.

## Indications for use
Pekkton® ivory is intended to be used for long-term, temporary dental crowns and bridges frameworks.

Source page: https://510kreport.com/device/K123638
Methodology: https://510kreport.com/methodology