# K013383: Biohex One-Piece One Stage Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Implant Technology, Inc.
- Decided: Jan 10, 2002 after 90 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
For implantatién into the fully or partially edentulous ridge for the support of a dental prosthesis or for single tooth replacement, in a single stage surgical procedure. The product is intended to be implanted with no-load conditions for 8-10 weeks after implantation.

Source page: https://510kreport.com/device/K013383
Methodology: https://510kreport.com/methodology