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FDA 510(k)

BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM

K-Number: K970499 · 1997-10-16

ApplicantNobel Biocare Uas, Inc.
Decision Date1997-10-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM 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 1997-10-16 under 510(k) number K970499. 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 ZYGOMATICUS FIXTURE SYSTEM?

BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM is a medical device that received FDA 510(k) clearance on 1997-10-16. The listed applicant is Nobel Biocare Uas, Inc.. The 510(k) number is K970499.

When did BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM receive FDA 510(k) clearance?

BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM received FDA 510(k) clearance on 1997-10-16, under 510(k) number K970499.

Who is the listed applicant for BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM?

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 ZYGOMATICUS FIXTURE SYSTEM?

The FDA product code for BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM 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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