# K052369: Exfeel Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Co., Ltd.
- Decided: Jan 10, 2006 after 134 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: 6 generations back to K944964 (1995). 53 ancestors in all.
84 later devices descend from it; 6 cite it directly.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041655: Bio Plant System (Implants and Abutments), Cowellmedi Co., Ltd. (2004) Summary page 1.
- K925777: Branemark System Estheticone Abutment Complete, Nobelpharma USA, Inc. (1993) Summary page 1.
- K925779: Branemark System Titanium Healing Abutments, Nobelpharma USA, Inc. (1993) Summary page 1.
- K961728: Miruscone Abutment System, Nobelpharma USA, Inc. (1996) Summary page 1.
- K971706: Tiadapt Abutment System, Nobel Biocare Uas, Inc. (1997) Summary page 1.
- K002374: Iti Dental Implant System Monotype Implant, Straumann USA (2000) Summary page 2.
- K993595: Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement), Nobel Biocare Uas, Inc. (2000) Summary page 2.

## Most influential descendants
- K070562: EZ Plus Implant System (2007), 74 descendants of its own
- K110955: Anyridge Internal Implant System (2011), 43 descendants of its own
- K122231: Xpeed Any Ridge Internal Implant System (2012), 25 descendants of its own
- K073486: Dentis Dental Implant System (2008), 25 descendants of its own
- K150344: Dentis Dental Implant System (2015), 20 descendants of its own

## Indications for use
The ExFeel Dental Implant Systems are intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure

Source page: https://510kreport.com/device/K052369
Methodology: https://510kreport.com/methodology