# K972417: The 6.0 X 8.0MM Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Bicon, Inc.
- Decided: Sep 17, 1997 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K103810: KJ Submerged System (2011), 1 descendant of its own
- K072595: Omni-Tight (2008), 1 descendant of its own
- K202046: LOTA SLA Dental Implant System and LOTA HA Dental Implant System (2022), 0 descendants of its own
- K082749: Omni-Tight (2008), 0 descendants of its own

## Indications for use
The 6.0 x 8.0mm implant is 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/K972417
Methodology: https://510kreport.com/methodology