# K141970: Digitek Titanium Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Digitek Dental Solutions Limited
- Decided: Jul 31, 2015 after 375 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: 11 generations back to K894595 (1990). 126 ancestors in all.
No later device cites it as a predicate yet.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100993: Inclusive Titanium Abutments for Astra Tech Osseospeed Implants, Prismatik Dentalcraft, Inc. (2010) Summary page 4.
- K103234: GC Aadva BO AC Abutments, GC America, Inc. (2011) Summary page 4.

## Indications for use
Digitek Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the ASTRA TECH Implant System OsseoSpeed™ 3.5mm, 4.0mm, 4.5mm, 5.0mm implants.

Source page: https://510kreport.com/device/K141970
Methodology: https://510kreport.com/methodology