# K050208: Friadent Estheticap

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International
- Decided: Jun 14, 2005 after 137 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K894595 (1990). 13 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974628: Frialit-2 Protect Abutment, Friatec AG (1998) Summary page 1.
- K013867: Xive Dental Implant System, Friadent GmbH (2002) Summary page 1.
- K023113: Replace Tiunite Endosseous Implant, Nobel Biocare Uas, Inc. (2002) Summary page 1.

## Most influential descendants
- K053099: Biohorizons Plastic Temporary Abutments (2006), 1 descendant of its own
- K122559: Biodenta Dental Implant System - Abutments (2013), 0 descendants of its own
- K073073: Ankylos Temporary Abutment Balance (2008), 0 descendants of its own

## Indications for use
FRIADENT® EsthetiCap is an anatomically shaped abutment used for fabrication of screw-retained or cementable temporary crowns or bridges. The FRIADENT® EsthetiCap is a short-term provisional abutment for esthetic shaping of soft tissue.

Source page: https://510kreport.com/device/K050208
Methodology: https://510kreport.com/methodology