# K160979: Inclusive Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Nov 4, 2016 after 211 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
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K170044: Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System (2017), 5 descendants of its own
- K191222: Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV (2019), 4 descendants of its own
- 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

## Indications for use
Inclusive” 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. Compatible Implant System Implant Diameter (mm) Platform Diameter (mm) Astra Tech OsseoSpeed™ 3.0,3.5,4.0,4.5,5.0 3.0,3.5,4.0,4.5,5.0 Biomet 3i Osseotite” Certain” 3.25,4.0,5.0,6.0 3.4,4.1,5.0,6.0 Camlog Screw-line 3.3,3.8,4.3,5.0,6.0 3.3,3.8,4.3,5.0,6.0 Dentsply Ankylos 3.5,4.5,55,7.0 3.5,4.5,5.5,7.0 Hahn Tapered Implant System 3.0,3.5,4.3,5.0,7.0 3.0,3.5,4.3,5.0,7.0 Hiossen HG Implant System mini, standard 3.5,4.0,45,5.0 37,4.2,4.6,5.1 Inclusive Tapered Implant System 3.7,4.7,5.2 35,45 Nobel Biocare Branemark RP 3.75,4.0 4.1 Nobel Biocare NobelActive™ NP, RP 35,43,5.0 35,39 Nobel Biocare NobelReplace™ NP, RP, WP, 6.0 3.5,4.3,5.0,6.0 3.5,4.3,5.0,6.0 Straumann Bone Level NC, RC 33,4.1,4.8 33,4.1,4.8 Straumann synOcta RN, WN 4.1,4.8 4.8,6.5 Zimmer Screw-Vent® 37,4.1,4.7,6.0 3.5,4.5,5.7 All digitally designed abutments for use with Inclusive® Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Source page: https://510kreport.com/device/K160979
Methodology: https://510kreport.com/methodology