# K083543: Denovismed Dental Implant Systems

- Pathway: 510(k) (Traditional)
- Applicant: Denovis Medical, LLC
- Decided: Mar 6, 2009 after 98 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
For immediate or delayed placement and function on single-tooth and/or multiple tooth applications in the maxillary or mandibular arches to support crowns, bridges, and overdentures in edentulous or partially edentulous patients. Immediate loading is indicated for single tooth and/or multiple tooth applications when there is good primary stability and an appropriate occlusal load.

Source page: https://510kreport.com/device/K083543
Methodology: https://510kreport.com/methodology