# K172560: PREMIUM ONE Implant Systems

- Pathway: 510(k) (Traditional)
- Applicant: Sweden & Martina S.P.A.
- Decided: Dec 21, 2017 after 118 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
PREMIUM ONE Implant Systems are intended for both one- and two-stage surgical procedures. PREMIUM ONE Implant Systems are intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.

Source page: https://510kreport.com/device/K172560
Methodology: https://510kreport.com/methodology