# K050712: 4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Bicon, Inc.
- Decided: Apr 22, 2005 after 36 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
No predicates in its family tree.
240 later devices descend from it; 9 cite it directly.
0 of 241 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K123022: Neodent Implant System (2013), 127 descendants of its own
- K133510: Neodent Implant System (2014), 123 descendants of its own
- K053353: Rescue Implant System (2006), 118 descendants of its own
- K063216: Rescue Internal Implant System (2007), 112 descendants of its own
- K133592: Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua and Drive Smart Acqua, Titamax CM (2014), 109 descendants of its own

## Indications for use
The 4.5 x 6.0mm and the 6.0 x 6.0mm implants are designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework, partial dentures, or a single tooth replacement.

Source page: https://510kreport.com/device/K050712
Methodology: https://510kreport.com/methodology