# K031674: Modification to Frialit-2 Dental Implant System

- Pathway: 510(k) (Special)
- Applicant: Friadent GmbH
- Decided: Aug 14, 2003 after 76 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
Longest line of descent: 2 generations back to K925765 (1993). 4 ancestors in all.
391 later devices descend from it; 2 cite it directly.
0 of 396 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945847: Frialit (R)-2 Stepped Screw with Deep Profile Surface, Friatec Medical Inc., USA (1996) Summary page 1.
- K974358: Frialit -2 Screw, Friatec AG (1998) Summary page 1.
- K994376: Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2 3.4MM Steeped Cylinder Implant with Frios HA, Friadent GmbH (2000) Summary page 1.

## Most influential descendants
- 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
- K111357: Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System (2011), 222 descendants of its own

## Indications for use
The FRIALITe2 Dental Implant System is indicated for use in single tooth restoration, edentulous spans restored with multiple single teeth, freestanding bridges and to retain overdentures. The implants can be used for immediate implant placement, delayed immediate or late implant placement.

Source page: https://510kreport.com/device/K031674
Methodology: https://510kreport.com/methodology