# K013438: Frialit-2 Estheticbase Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Friadent GmbH
- Decided: Dec 20, 2001 after 64 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.
14 later devices descend from it; 1 cites it directly.
0 of 15 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
- K971706: Tiadapt Abutment System, Nobel Biocare Uas, Inc. (1997). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K122424: Isus Implant Suprastructures (2013), 13 descendants of its own
- K160207: ATLANTIS ISUS Implant Suprastructures (2016), 5 descendants of its own
- K212676: Osteon Precision Milled Suprastructure (2022), 4 descendants of its own
- K163350: Multibase Abutments EV and ATLANTIS Suprastructures (2017), 4 descendants of its own
- K221019: Osteon Precision Milled Suprastructure (2022), 3 descendants of its own

## Indications for use
The FRLALIT-26D EstheticBase Abutment is intended fbf use to fabricate screw-retained or cemeatabIe crowns and bridges.

Source page: https://510kreport.com/device/K013438
Methodology: https://510kreport.com/methodology