# K041655: Bio Plant System (Implants and Abutments)

- Pathway: 510(k) (Abbreviated)
- Applicant: Cowellmedi Co., Ltd.
- Decided: Sep 8, 2004 after 82 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: 5 generations back to K944964 (1995). 51 ancestors in all.
91 later devices descend from it; 2 cite it directly.
0 of 143 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K993595: Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement), Nobel Biocare Uas, Inc. (2000) Summary page 1.
- K022562: Various Branemark System Implants-Immediate Function Indication, Nobel Biocare AB (2002) Summary page 1.
- K971706: Tiadapt Abutment System, Nobel Biocare Uas, Inc. (1997) Summary page 1.
- K974150: Procera Preparable Abutment System, Nobel Biocare Uas, Inc. (1998) Summary page 1.
- K992937: Dental Implant, Nobel Biocare Uas, Inc. (2000) Summary page 1.
- K022009: 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants, Implant Innovations, Inc. (2002) Summary page 1.
- K983347: Osseotite Dental Implants, Implant Innovations, Inc. (1999) Summary page 1.
- K965077: Single Toot Abutment System (Sta or ST Abutment ) for Single Ooth Cement Retained Restorations, Implant Innovations, Inc. (1997) Summary page 1.
- K934126: One and Two Piece Temporary Healing,(Emergence Profile) Abutments, Implant Innovations, Inc. (1994) Summary page 1.
- K935544: 3I Standard Threaded/Self-Tapping Threaded Implants Modification, Implant Innovations International, Inc. (1995) Summary page 1.
- K022113: 3I Dental Implant Accessories, Implant Innovations, Inc. (2002) Summary page 1.

## Most influential descendants
- K052369: Exfeel Implant System (2006), 84 descendants of its own
- 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

## Indications for use
BioPlant Systems refer to sets of root form endosseous dental implants and compatible implant abutment systems. BioPlant Systems are designed for use in dental implant surgery and are intended to be used in a manor in which they (the implants) integrate with the bone (osseointegration). The BioPlant abutment systems include various abutments designed to enable the implant process from healing thru final restoration. Clinical studies have demonstrated that, when surgically implanted under controlled conditions, a successfully osseointegrated implant will achieve a firm and direct connection between the living bone and surface of the titanium implant. BioPlant implants are for single or two-stage surgical procedures. BioPlant Systems are intended for immediate placement in partially or fully edentulous mandibles and maxillae (type I or II bone), in support of single or multiple-unit restorations including; cemented retained, screw retained, or over-denture restorations, and terminal or intermediate abutment support for fixed bridgework. Multiple tooth applications may be splinted with a bar.

Source page: https://510kreport.com/device/K041655
Methodology: https://510kreport.com/methodology