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FDA 510(k)

SENOJ IMPLANT SYSTEM

K-Number: K000889 · 2001-04-27

ApplicantSenoj Biocare, Inc.
Decision Date2001-04-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SENOJ IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Senoj Biocare, Inc.. It received FDA 510(k) clearance on 2001-04-27 under 510(k) number K000889. 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 SENOJ IMPLANT SYSTEM?

SENOJ IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2001-04-27. The listed applicant is Senoj Biocare, Inc.. The 510(k) number is K000889.

When did SENOJ IMPLANT SYSTEM receive FDA 510(k) clearance?

SENOJ IMPLANT SYSTEM received FDA 510(k) clearance on 2001-04-27, under 510(k) number K000889.

Who is the listed applicant for SENOJ IMPLANT SYSTEM?

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

What is the FDA product code for SENOJ IMPLANT SYSTEM?

The FDA product code for SENOJ IMPLANT SYSTEM is DZE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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