# K254063: iCEM Universal Plus

- Pathway: 510(k) (Abbreviated)
- Applicant: Kulzer, LLC
- Decided: Dec 19, 2025 after 2 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K931812 (1993). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200798: G-Cem One, GC America, Inc. (2020) Summary page 5.

## Indications for use
Bonding of indirect restorations made of composite, all-ceramic and metal. Bonding of prosthetic devices (crowns, inlays, onlays, bridges, and veneers) to cavities, abutment teeth, or implant abutments. Dental core bonding.

Source page: https://510kreport.com/device/K254063
Methodology: https://510kreport.com/methodology