# K211308: Inni-Cera

- Pathway: 510(k) (Traditional)
- Applicant: Aon Co., Ltd.
- Decided: Oct 4, 2021 after 158 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 K051705 (2005). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051705: Ips E.Max Cad/Ips E.Max Zircad, Ivoclar Vivadent, Inc. (2005) Summary page 5.

## Most influential descendants
- K240419: UltraThineer Zirconia Slurry (5Y-B) (2024), 0 descendants of its own

## Indications for use
INNI-CERA is indicated for use by dental technicians in the construction of custom-made all ceramic restorations. Coping Crown Inlay & Onlay Veneer Bridge(3-unit anterior bridges)

Source page: https://510kreport.com/device/K211308
Methodology: https://510kreport.com/methodology