# K142115: Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare Implant

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Nov 13, 2014 after 101 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K925765 (1993). 124 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073217: Inclusive Implant Abutments, Inclusive Dental Solutions (2008) Summary page 5.
- K091756: Nobelprocera TI Abutment, Nobel Biocare AB (2009) Summary page 5.
- K072642: Biomet 3I Dental Abutments and Restorative Components, Biomet 3i, Inc. (2007) Summary page 5.
- K092403: TI Prepable Abutment, Model 1618, 1619, 1620, Zimmer Dental, Inc. (2009) Summary page 5.

## Most influential descendants
- K151295: Biodenta Customized Abutment - Titanium (2015), 1 descendant of its own
- K231210: DGA Abutment (2024), 0 descendants of its own

## Recalls of this device
- Sep 30, 2025 · Class II · Z-0417-2026: Incorrect titanium screw, packaged with dental implant.

## Indications for use
Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive® Titanium Abutments are compatible with: - Biomet: 3i Certain internal hex implants in 3.4, 4.1, 5.0, 6.0 mm sizes - Nobel Biocare: NobelReplace straight and tapered internal connection implants in NP, RP, WP, 6.0 mm sizes - Zimmer: Screw-Vent and Tapered Screw-Vent internal hex implants in 3.5, 4.5, 5.7 mm sizes

Source page: https://510kreport.com/device/K142115
Methodology: https://510kreport.com/methodology