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FDA 510(k)

FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS

K-Number: K073075 · 2008-03-31

ApplicantDentsply International, Inc.
Decision Date2008-03-31
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International, Inc.. It received FDA 510(k) clearance on 2008-03-31 under 510(k) number K073075. 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 FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS?

FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS is a medical device that received FDA 510(k) clearance on 2008-03-31. The listed applicant is Dentsply International, Inc.. The 510(k) number is K073075.

When did FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS receive FDA 510(k) clearance?

FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS received FDA 510(k) clearance on 2008-03-31, under 510(k) number K073075.

Who is the listed applicant for FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS?

The FDA 510(k) record lists Dentsply International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS?

The FDA product code for FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL 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.

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