# K994037: The 4.5MM Diameter Bicon Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Bicon, Inc.
- Decided: Jan 11, 2000 after 43 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.
6 later devices descend from it; 3 cite it directly.
0 of 7 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
- K050586: Leone Implant System (2006), 2 descendants of its own
- K103810: KJ Submerged System (2011), 1 descendant of its own
- K202046: LOTA SLA Dental Implant System and LOTA HA Dental Implant System (2022), 0 descendants of its own
- K092674: Simpler Toadstool Mini Implant (2009), 0 descendants of its own
- K070483: Leone Monoimplant for O-Ring Overdenture (2007), 0 descendants of its own

## Indications for use
The 4.5mm diameter 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 bridge work, partial dentures, and / or a single tooth replacement.

Source page: https://510kreport.com/device/K994037
Methodology: https://510kreport.com/methodology