NobelZygoma 0°
K-Number: K161598 · 2017-03-14
ApplicantNobel Biocare AB
Decision Date2017-03-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
NobelZygoma 0° is a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2017-03-14 under approval number K161598. 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 NobelZygoma 0°?
NobelZygoma 0° is a medical device that received FDA 510(k) clearance on 2017-03-14. It is manufactured by Nobel Biocare AB. The 510(k) number is K161598.
When was NobelZygoma 0° approved by the FDA?
NobelZygoma 0° received FDA 510(k) clearance on 2017-03-14, under approval number K161598.
What company makes NobelZygoma 0°?
NobelZygoma 0° is manufactured by Nobel Biocare AB.
What is the FDA product code for NobelZygoma 0°?
The FDA product code for NobelZygoma 0° 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.