PREMIUM ONE Implant Systems
K-Number: K172560 · 2017-12-21
Device Summary
Frequently Asked Questions
What is the PREMIUM ONE Implant Systems?
PREMIUM ONE Implant Systems is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Sweden & Martina S.P.A.. The 510(k) number is K172560.
When did PREMIUM ONE Implant Systems receive FDA 510(k) clearance?
PREMIUM ONE Implant Systems received FDA 510(k) clearance on 2017-12-21, under 510(k) number K172560.
Who is the listed applicant for PREMIUM ONE Implant Systems?
The FDA 510(k) record lists Sweden & Martina S.P.A. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PREMIUM ONE Implant Systems?
The FDA product code for PREMIUM ONE Implant Systems is DZE.
Other records listing Sweden & Martina S.P.A. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: DZE)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.