# K231097: Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Nov 14, 2023 after 210 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: 13 generations back to K894595 (1990). 180 ancestors in all.
No later device cites it as a predicate yet.
0 of 181 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191222: Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV, Prismatik Dentalcraft, Inc. (2019) Summary page 5.

## Indications for use
Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations. All digitally designed abutments for use with Inclusive® Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture. Compatible Implant System: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Compatible Implant Fixtures Implant Body Diameter Implant Platform Diameter Neoss® ProAtive® Narrow 3.25mm Narrow Platform (NP) Neoss® ProAtive® Standard 3.5mm Standard Platform (SP) 4.0mm 45mm 5.0 mm 5.5 mm MIS= SEVEN® 3.3 mm Narrow Platform (NP) 3.75 mm Standard Platform (SP) 4.2mm 5.0 mm Wide Platform (WP) 6.0 mm Zimmer® Eztetic® 3.1 mm 2.9 mm

Source page: https://510kreport.com/device/K231097
Methodology: https://510kreport.com/methodology