# K974358: Frialit -2 Screw

- Pathway: 510(k) (Traditional)
- Applicant: Friatec AG
- Decided: Feb 10, 1998 after 83 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.
392 later devices descend from it; 1 cites it directly.
0 of 393 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K031674: Modification to Frialit-2 Dental Implant System (2003), 391 descendants of its own
- K033984: Straumann Dental Implant System (2004), 376 descendants of its own
- K053088: Slactive Implants (2006), 295 descendants of its own
- K083550: Straumann Dental Implant System (2009), 228 descendants of its own
- K060958: Straumann Narrow Neck Implants (2006), 228 descendants of its own

## Indications for use
FRIALIT-2 implants are indicated for single tooth replacement, as immediate abutments on span to bridgework, as distal abutments on free-end areas to be restored with fixed work, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxilla.

Source page: https://510kreport.com/device/K974358
Methodology: https://510kreport.com/methodology