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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare AB. It received FDA 510(k) clearance on 2016-04-11 under 510(k) 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. The listed applicant is Nobel Biocare AB. The 510(k) number is K152836.

When did TREFOIL System receive FDA 510(k) clearance?

TREFOIL System received FDA 510(k) clearance on 2016-04-11, under 510(k) number K152836.

Who is the listed applicant for TREFOIL System?

The FDA 510(k) record lists Nobel Biocare AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TREFOIL System?

The FDA product code for TREFOIL System is DZE.

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Related Devices (Code: 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.

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