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FDA 510(k)

BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE

K-Number: K945398 · 1995-04-13

ApplicantNobelpharma USA, Inc.
Decision Date1995-04-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE is the device name listed in this FDA 510(k) record. The listed applicant is Nobelpharma USA, Inc.. It received FDA 510(k) clearance on 1995-04-13 under 510(k) number K945398. 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) MKII SELF-TAPPING FIXTURE?

BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE is a medical device that received FDA 510(k) clearance on 1995-04-13. The listed applicant is Nobelpharma USA, Inc.. The 510(k) number is K945398.

When did BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE receive FDA 510(k) clearance?

BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE received FDA 510(k) clearance on 1995-04-13, under 510(k) number K945398.

Who is the listed applicant for BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE?

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

What is the FDA product code for BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE?

The FDA product code for BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE is DZE.

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Other records listing Nobelpharma USA, 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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