TREFOIL System
K-Number: K152836 · 2016-04-11
ApplicantNobel Biocare AB
Decision Date2016-04-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TREFOIL System is a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2016-04-11 under approval number K152836. 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 TREFOIL System?
TREFOIL System is a medical device that received FDA 510(k) clearance on 2016-04-11. It is manufactured by Nobel Biocare AB. The 510(k) number is K152836.
When was TREFOIL System approved by the FDA?
TREFOIL System received FDA 510(k) clearance on 2016-04-11, under approval number K152836.
What company makes TREFOIL System?
TREFOIL System is manufactured by Nobel Biocare AB.
What is the FDA product code for TREFOIL System?
The FDA product code for TREFOIL System 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.