# K010185: 6.0 X 5.7MM Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Bicon, Inc.
- Decided: Dec 30, 2002 after 710 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.
234 later devices descend from it; 8 cite it directly.
0 of 235 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K010185
Methodology: https://510kreport.com/methodology