# K980630: Frialit-2 Corabase

- Pathway: 510(k) (Traditional)
- Applicant: Friatec AG
- Decided: Sep 4, 1998 after 198 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K961737: Cera One Abutment System, Nobelpharma USA, Inc. (1996). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K072730: Friadent Cercon and Ankylos Cercon Balance Abutments (2008), 0 descendants of its own
- K014175: Sulzer Dental Ceramic System-Hexlock (2002), 0 descendants of its own
- K014214: Sulzer Dental Ceramic System-Spline (2002), 0 descendants of its own

## Indications for use
The FRIALIT-2® CeraBase abutment is intended for use in the fabrication of single crowns for the anterior maxilla and mandible where exceptional esthetics are required.

Source page: https://510kreport.com/device/K980630
Methodology: https://510kreport.com/methodology