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FDA 510(k)

BRANEMARK SYSTEM(R) EBON(TM) FIXTURE

K-Number: K974828 · 1998-03-24

ApplicantNobel Biocare Uas, Inc.
Decision Date1998-03-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRANEMARK SYSTEM(R) EBON(TM) FIXTURE is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare Uas, Inc.. It received FDA 510(k) clearance on 1998-03-24 under 510(k) number K974828. 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 BRANEMARK SYSTEM(R) EBON(TM) FIXTURE?

BRANEMARK SYSTEM(R) EBON(TM) FIXTURE is a medical device that received FDA 510(k) clearance on 1998-03-24. The listed applicant is Nobel Biocare Uas, Inc.. The 510(k) number is K974828.

When did BRANEMARK SYSTEM(R) EBON(TM) FIXTURE receive FDA 510(k) clearance?

BRANEMARK SYSTEM(R) EBON(TM) FIXTURE received FDA 510(k) clearance on 1998-03-24, under 510(k) number K974828.

Who is the listed applicant for BRANEMARK SYSTEM(R) EBON(TM) FIXTURE?

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

What is the FDA product code for BRANEMARK SYSTEM(R) EBON(TM) FIXTURE?

The FDA product code for BRANEMARK SYSTEM(R) EBON(TM) FIXTURE is DZE.

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Other records listing Nobel Biocare Uas, Inc. as applicant

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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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