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FDA 510(k)

BRANEMARK SYSTEM DEC 600 DRILLING UNIT

K-Number: K974123 · 1998-05-26

ApplicantNobel Biocare Uas, Inc.
Decision Date1998-05-26
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRANEMARK SYSTEM DEC 600 DRILLING UNIT 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 1998-05-26 under 510(k) number K974123. 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 DEC 600 DRILLING UNIT?

BRANEMARK SYSTEM DEC 600 DRILLING UNIT is a medical device that received FDA 510(k) clearance on 1998-05-26. The listed applicant is Nobel Biocare Uas, Inc.. The 510(k) number is K974123.

When did BRANEMARK SYSTEM DEC 600 DRILLING UNIT receive FDA 510(k) clearance?

BRANEMARK SYSTEM DEC 600 DRILLING UNIT received FDA 510(k) clearance on 1998-05-26, under 510(k) number K974123.

Who is the listed applicant for BRANEMARK SYSTEM DEC 600 DRILLING UNIT?

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 DEC 600 DRILLING UNIT?

The FDA product code for BRANEMARK SYSTEM DEC 600 DRILLING UNIT 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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