NobelSpeedy Groovy
K-Number: K160119 · 2016-06-02
ApplicantNobel Biocare AB
Decision Date2016-06-02
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
NobelSpeedy Groovy is a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2016-06-02 under approval number K160119. 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 NobelSpeedy Groovy?
NobelSpeedy Groovy is a medical device that received FDA 510(k) clearance on 2016-06-02. It is manufactured by Nobel Biocare AB. The 510(k) number is K160119.
When was NobelSpeedy Groovy approved by the FDA?
NobelSpeedy Groovy received FDA 510(k) clearance on 2016-06-02, under approval number K160119.
What company makes NobelSpeedy Groovy?
NobelSpeedy Groovy is manufactured by Nobel Biocare AB.
What is the FDA product code for NobelSpeedy Groovy?
The FDA product code for NobelSpeedy Groovy 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.