# K083192: Inclusive Titanium Abutment Blanks

- Pathway: 510(k) (Abbreviated)
- Applicant: Inclusive Dental Solutions
- Decided: Mar 4, 2009 after 126 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: 8 generations back to K894595 (1990). 69 ancestors in all.
40 later devices descend from it; 6 cite it directly.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042658: Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004, Nobel Biocare Uas, Inc. (2004) Summary page 1.
- K071370: Nobelactive Internal Connection Implant, Nobel Biocare AB (2007) Summary page 1.
- K062129: P.0004 Implants, Institut Straumann AG (2006) Summary page 1.

## Most influential descendants
- K103291: Biohorizons Laser-Lok Abutments for Nobel Biocare (2011), 30 descendants of its own
- K122295: Core 3D Abutment System for Digital Prosthetic Solutions (2013), 29 descendants of its own
- K151621: BioHorizons CAD/CAM Abutments (2016), 26 descendants of its own
- K183518: Preat Abutments (2019), 22 descendants of its own
- K193096: S.I.N. Dental Implant System (2020), 8 descendants of its own

## Indications for use
The Inclusive Titanium Abutment Blank is intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. Inclusive Titanium Abutment Blanks for Nobel Biocare are compatible with NobelActive Internal NP and RP implants. Inclusive Titanium Abutment Blanks for Institut Straumann are compatible with Straumann Bone Level implants in the NC and RC platform sizes. Inclusive Titanium Abutment Blanks for the Nobel Biocare Branemark System are compatible with the Branemark RP size implant. Abutments with angulations greater than 20 degrees on implants less than 4mm in diameter are not indicated for the posterior region because of strength limitations of the implant.

Source page: https://510kreport.com/device/K083192
Methodology: https://510kreport.com/methodology