# K982576: Frialit-2 Aurobase Model Numbers 45-2446, 45-2456, 45-2466, 45-2476

- Pathway: 510(k) (Traditional)
- Applicant: Friatec AG
- Decided: Oct 22, 1998 after 90 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 K874400 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874400: Non-Rotating Gold Cylinder and Screw, Implant Innovations International, Inc. (1988) Summary page 1.

## Indications for use
THE FRIALIT-2® AUROBASE ABUTMENT IS INTENDED FOR USE IN FABRICATION OF MULTIPLE UNIT RESTORATIONS, SINGLE TOOTH RESTORATIONS, CUSTOM ABUTMENTS AND LABORATORY-CONSTRUCTED ANGLED ABUTMENTS IN THE MAXILLA AND MANDIBLE.

Source page: https://510kreport.com/device/K982576
Methodology: https://510kreport.com/methodology