# K100932: Inclusive Mini Implant

- Pathway: 510(k) (Abbreviated)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Dec 27, 2010 after 266 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: 1 generation back to K031106 (2003). 1 ancestor in all.
15 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031106: Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX, Imtec Corp. (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- K081655: Powder Free Vinyl Patient Examination Gloves (Light Yellow), Jiangsu Cureguard Glove Co., Ltd. (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K121406: Inclusive Tapered Implant System (2013), 11 descendants of its own
- 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

## Indications for use
Inclusive Mini Implants are self-tapping threaded titanium screws indicated for long-term applications. Inclusive Mini Implants may also be used for provisional applications. These devices will allow immediate loading and long-term stabilization of dentures and provisional stabilization of dentures while standard implants heal. To be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.

Source page: https://510kreport.com/device/K100932
Methodology: https://510kreport.com/methodology