# K980374: Implant Site Dilators

- Pathway: 510(k) (Traditional)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Mar 4, 1998 after 33 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. The FDA summary names no predicate by number.

## Indications for use
BioHorizons Implant Site Dilators are indicated for use to aid in the placement of root form implants in soft maxillary bone. Rather than removing valuable bone from the surgical site, the function of these instruments is to manually form the osteotomy by compressing the bone laterally, causing a denser bone to implant interface.

Source page: https://510kreport.com/device/K980374
Methodology: https://510kreport.com/methodology