# K945849: Frialit (R)-2 Stepped Cylinder with Frios (R) TI-Coating

- Pathway: 510(k) (Traditional)
- Applicant: Friatec Medical Inc., USA
- Decided: Mar 15, 1996 after 471 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K994174: Frialit-2 MH-2 Abutment (2000), 3 descendants of its own
- K122268: Angled Xive MP Abutment, Angled Ankylos (2012), 2 descendants of its own
- K131644: Ankylos Syncone Abutment 5(Degree) (2014), 1 descendant of its own
- K151439: Atlantis Isus (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K945849
Methodology: https://510kreport.com/methodology