# K240888: Calibra Abutment Resin Cement

- Pathway: 510(k) (Special)
- Applicant: Dentsply Sirona
- Decided: Apr 2, 2024 after 1 day
- 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: 2 generations back to K090704 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130436: Multilink Hybrid Abutment Cement, Ivoclar Vivadent, AG (2013) Summary page 4.

## Indications for use
Calibra Abutment Resin Cement is indicated for the cementation of: Extraoral assembly of prosthetic components, e.g., structures made of ceramic or zirconia onto custom or pre-fabricated titanium/titanium alloy or zirconia bases/implant inserts/abutments, e.g., InCoris ZI and CEREC Tesseram Abutment Block prostheses and mesostructures to TiBases.

Source page: https://510kreport.com/device/K240888
Methodology: https://510kreport.com/methodology