# K073368: 5.0 X 5.0MM Dental Implant and 6.0 X 5.0 Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Bicon, LLC
- Decided: Oct 10, 2008 after 315 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.
17 later devices descend from it; 5 cite it directly.
0 of 18 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
- K130572: Interactive/ SWISHPLUS2 Implant System (2013), 10 descendants of its own
- K143011: 2014 InterActive/SwishActive System (2015), 8 descendants of its own
- K181359: InterActive SMARTBase Abutments (2018), 6 descendants of its own
- K193084: TIB Abutment System (2020), 3 descendants of its own
- K191458: Legacy SMARTBase Abutments (2019), 1 descendant of its own

## Indications for use
The 5.0 x 5.0mm and the 6.0 x 5.0mm implants are designed as a one stage or two stage surgical procedure implant 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/K073368
Methodology: https://510kreport.com/methodology