# K083480: Inclusive Zirconia Abutment Blanks

- Pathway: 510(k) (Abbreviated)
- Applicant: Inclusive Dental Solutions
- Decided: May 5, 2009 after 162 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: 10 generations back to K944964 (1995). 100 ancestors in all.
27 later devices descend from it; 2 cite it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072642: Biomet 3I Dental Abutments and Restorative Components, Biomet 3i, Inc. (2007) Summary page 1.
- K011028: Screw-Vent Dental Implant System, Sulzer Dental, Inc. (2001)
- K063341: 3I Osseotite Certain Dental Implants, Implant Innovations, Inc. (2007) Summary page 1.
- K023113: Replace Tiunite Endosseous Implant, Nobel Biocare Uas, Inc. (2002) Summary page 1.
- K062277: Atlantis Abutment in Zirconia for Nobel Biocare Replace, Atlantis Components, Inc. (2006) Summary page 1.
- K072483: Atlantis Abutment in Zirconia for 3I Certain Microamini Implants, Gemini Abutment in Zirconia for Astra Implants, Atlantis Components, Inc. (2007) Summary page 1.

## Most influential descendants
- K132125: A.B. Dental Devices Dental Implants System (2014), 25 descendants of its own
- K140440: Noris Medical Dental Implants System (2014), 14 descendants of its own
- K151909: Noris Medical Zygomatic Dental Implant System (2016), 7 descendants of its own
- K162482: A.B. DENTAL DEVICES Dental Implants System (2017), 4 descendants of its own
- K183024: Implacil Implant System (2020), 2 descendants of its own

## Indications for use
The Inclusive Zirconia 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 Zirconia Abutment Blanks for Zimmer Implants are compatible with Zimmer Screw Vent and Tapered Screw Vent internal hex implants. Inclusive Zirconia Abutment Blanks for 3i Implant are compatible with 3i Certain internal hex implants. Inclusive Zirconia Abutment Blanks for Nobel Biocare Implant are compatible with Nobel Biocare Replace straight and tapered internal-connection implants. Abutments with angulations greater than 20 degrees are contraindicated.

Source page: https://510kreport.com/device/K083480
Methodology: https://510kreport.com/methodology