# K161269: CELTRA Press

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Aug 12, 2016 after 99 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K120134 (2012). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120134: Ips E.Max Press Multi, Ivoclar Vivadent, AG (2012) Summary page 4.

## Most influential descendants
- K162888: Cercon (2017), 1 descendant of its own
- K241557: Cercon® yo ML (2024), 0 descendants of its own

## Indications for use
CELTRA Press is an all-ceramic system for the creation of Occlusal veneers Thin veneers Veneers Inlays Onlays Crowns in the anterior and posterior region 3-unit bridges in the anterior and posterior region 3-unit bridges in the premolar region up to the second premolar as the terminal abutment Crown, splinted crown or 3 unit bridge up to the second premolar placed on top of an implant abutment.

Source page: https://510kreport.com/device/K161269
Methodology: https://510kreport.com/methodology