# K143515: Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Oct 1, 2015 after 294 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: 11 generations back to K944964 (1995). 101 ancestors in all.
No later device cites it as a predicate yet.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083480: Inclusive Zirconia Abutment Blanks, Inclusive Dental Solutions (2009) Summary page 4.

## Indications for use
Inclusive® Zirconia Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive® Zirconia Abutments are compatible with the following bone-level implants: Biomet 3i™ Certain® internal hex implants with 3.4, 4.1, 5.0, 6.0 mm platform diameters Nobel Biocare NobelReplace® straight and tapered internal connection implants with NP, RP, WP, 6.0 mm platform diameters Zimmer Dental Screw-Vent® and Tapered Screw-Vent® internal hex implants with 3.5, 4.5, 5.7 mm platform diameters (excluding 3.3 mmD Screw-Vent implants)

Source page: https://510kreport.com/device/K143515
Methodology: https://510kreport.com/methodology