# K121406: Inclusive Tapered Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Feb 22, 2013 after 288 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: 2 generations back to K031106 (2003). 4 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100932: Inclusive Mini Implant, Prismatik Dentalcraft, Inc. (2010) Summary page 2.
- K011028: Screw-Vent Dental Implant System, Sulzer Dental, Inc. (2001) Summary page 2.
- K953235: Screw Implants, Grade 3; Uncoated, HA, TP-K3, The Implant Center of the Palm Beaches (1995) Summary page 2.

## Most influential descendants
- K143353: Hahn Tapered Implant System (2015), 10 descendants of its own
- K170044: Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System (2017), 5 descendants of its own
- K191222: Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV (2019), 4 descendants of its own
- K153099: Inclusive Tapered Implant System (2016), 3 descendants of its own
- K171728: MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm (2017), 2 descendants of its own

## Indications for use
Inclusivee Tapered Implants are indicated for use in maxiliay and mandibular partially or fidly edentmujou cases to support Single, mnultiple-unit, and overden~tute estorations The implants are to be used for immediate loading only in the presence of primary stability and appropriate occlusal

Source page: https://510kreport.com/device/K121406
Methodology: https://510kreport.com/methodology