# K141923: Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/X

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Jan 6, 2015 after 174 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: 10 generations back to K944964 (1995). 84 ancestors in all.
No later device cites it as a predicate yet.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101004: Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis Gemini + Abutment, Astra Tech, Inc. (2010) Summary page 5.
- K083192: Inclusive Titanium Abutment Blanks, Inclusive Dental Solutions (2009) Summary page 5.

## Indications for use
Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive Titanium Abutments are compatible with Dentsply Implants Ankylos® C/X in 3.5, 4.5, 5.5, 7.0 mm sizes.

Source page: https://510kreport.com/device/K141923
Methodology: https://510kreport.com/methodology