# K994376: Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2 3.4MM Steeped Cylinder Implant with Frios HA

- Pathway: 510(k) (Traditional)
- Applicant: Friadent GmbH
- Decided: Mar 24, 2000 after 88 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: 1 generation back to K925765 (1993). 1 ancestor in all.
665 later devices descend from it; 6 cite it directly.
0 of 667 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925765: Branemark System Standard 3.75MM Fixture, Nobelpharma USA, Inc. (1993) Summary page 1.
- (no number) FRIALIT-2® Dental Implant Systems: named in the summary without a submission number

## Most influential descendants
- K014235: Osseotite NT Dental Implants & Accessories (2002), 583 descendants of its own
- K022009: 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants (2002), 478 descendants of its own
- 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
- K062069: Atlantis Abutment for 3I Micromini Implant (2007), 361 descendants of its own

## Indications for use
The FRIALIT-2® Dental Implant System is intended for use in single tooth restoration, edentulous spans restored with multiple single teeth, free-standing bridges and to retain overdentures. The implants can be used after extraction for immediate implant placement, delayed immediate implant placement or late implant placement.

Source page: https://510kreport.com/device/K994376
Methodology: https://510kreport.com/methodology