# K191222: Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Aug 5, 2019 after 90 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: 12 generations back to K894595 (1990). 179 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170044: Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System, Prismatik Dentalcraft, Inc. (2017) Summary page 4.
- K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 4.

## Most influential descendants
- K252582: Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems (2025), 0 descendants of its own
- K240240: Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems (2024), 0 descendants of its own
- K231097: Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems (2023), 0 descendants of its own
- K223496: Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems (2023), 0 descendants of its own

## Indications for use
Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in the 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: Dentsply Implants Astra Tech Implant System® EV Compatible Implant Fixtures Implant Body Diameter Implant Platform Diameter OsseoSpeed® EV 3.0S 3.0 mm 3.0 mm OsseoSpeed® EV 3.6S 3.6 mm 3.6 mm OsseoSpeed® EV 4.2S 4.2 mm 4.2 mm OsseoSpeed® EV 4.2C 3.6 mm 4.2 mm OsseoSpeed® EV 4.8S 4.8 mm 4.8 mm OsseoSpeed® EV 4.8C 4.2 mm 4.8 mm OsseoSpeed® EV 5.4S 5.4 mm 5.4 mm

Source page: https://510kreport.com/device/K191222
Methodology: https://510kreport.com/methodology