# K073217: Inclusive Implant Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Inclusive Dental Solutions
- Decided: May 14, 2008 after 181 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: 9 generations back to K925765 (1993). 103 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063341: 3I Osseotite Certain Dental Implants, Implant Innovations, Inc. (2007) Summary page 1.
- K072642: Biomet 3I Dental Abutments and Restorative Components, Biomet 3i, Inc. (2007). Cleared while this submission was under review Summary page 1.
- 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.
- K022425: Screwline, Altatec Biotechnologies N.A., Inc. (2002) Summary page 1.
- K041275: Procera Abutment Octagon, Nobel Biocare Uas, Inc. (2004) Summary page 1.
- K061847: Zimmer Contour Ceramic Abutment, Models ZRA341S, ZRA342S, KRA451S, ZRA452S, Zimmer Dental, Inc. (2006) Summary page 1.
- K071439: Zimmer Patient-Specific Abutment, Internal Hex, Titanium, Zimmer Dental, Inc. (2007) Summary page 1.

## Most influential descendants
- K142115: Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare Implant (2014), 2 descendants of its own
- K151295: Biodenta Customized Abutment - Titanium (2015), 1 descendant of its own
- K231210: DGA Abutment (2024), 0 descendants of its own

## Indications for use
The Inclusive Abutment 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. The Inclusive Abutment for Zimmer Implant is compatible with Zimmer Screw Vent and Tapered Screw Vent internal hex implants. The Inclusive Abutment for 31 Implant is compatible with 3i Certain internal hex implants. The Inclusive Abutment for Nobel Biocare Implant is compatible with Nobel Biocare Replace straight and tapered internal-connection implants. Please note: This device may be used in an early load situation, dependent on the specific implant system and protocol used by the dental professional; and, highly angled abutments (i.e. 20 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

Source page: https://510kreport.com/device/K073217
Methodology: https://510kreport.com/methodology