# K153099: Inclusive Tapered Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: May 23, 2016 after 210 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K031106 (2003). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121406: Inclusive Tapered Implant System, Prismatik Dentalcraft, Inc. (2013) Summary page 4.
- K143353: Hahn Tapered Implant System, Prismatik Dentalcraft, Inc. (2015) Summary page 4.

## Most influential descendants
- K171728: MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm (2017), 2 descendants of its own
- K213576: Tatum Surgical Dental Implant System (2022), 1 descendant of its own
- K254145: Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) (2026), 0 descendants of its own

## Indications for use
Inclusive Tapered Implant System is indicated for use in maxillary and mandibular partially or fully edentulous cases, to support single, multiple-unit, and overdenture restorations. The implants are to be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.

Source page: https://510kreport.com/device/K153099
Methodology: https://510kreport.com/methodology