PRAMA White Implant Systems
K-Number: K180365 · 2019-07-08
ApplicantSweden & Martina S.P.A.
Decision Date2019-07-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
PRAMA White Implant Systems is a medical device manufactured by Sweden & Martina S.P.A.. It received FDA 510(k) clearance on 2019-07-08 under approval number K180365. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
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. It is manufactured by Sweden & Martina S.P.A.. The 510(k) number is K180365.
When was PRAMA White Implant Systems approved by the FDA?
PRAMA White Implant Systems received FDA 510(k) clearance on 2019-07-08, under approval number K180365.
What company makes PRAMA White Implant Systems?
PRAMA White Implant Systems is manufactured by Sweden & Martina S.P.A..
What is the FDA product code for PRAMA White Implant Systems?
The FDA product code for PRAMA White Implant Systems is DZE.
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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.