# K141503: Denali 501CEMENT

- Pathway: 510(k) (Traditional)
- Applicant: Denali Corporation
- Decided: Nov 10, 2014 after 157 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: 1 generation back to K971372 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132393: Cercom II Cement, Denali Corporation (2014) Summary page 4.
- K971372: Variolink II, Ivoclar North America, Inc. (1997) Summary page 4.
- K053565: Tempbond Clear with Triclosan, Sybron Dental Specialties, Inc. (2006) Summary page 4.

## Indications for use
Denali 501 Cement is a two part, resin-based cement recommended for the bonding of ceramic, metal and composite restorations. For Use only by a Licensed Dentist. Rx Use Only.

Source page: https://510kreport.com/device/K141503
Methodology: https://510kreport.com/methodology