PRAMA White Implant Systems
K-Number: K180365 · 2019-07-08
Device Summary
Frequently Asked Questions
What is the PRAMA White Implant Systems?
PRAMA White Implant Systems is a medical device that received FDA 510(k) clearance on 2019-07-08. The listed applicant is Sweden & Martina S.P.A.. The 510(k) number is K180365.
When did PRAMA White Implant Systems receive FDA 510(k) clearance?
PRAMA White Implant Systems received FDA 510(k) clearance on 2019-07-08, under 510(k) number K180365.
Who is the listed applicant for PRAMA White 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 PRAMA White Implant Systems?
The FDA product code for PRAMA White 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.