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FDA 510(k)

BRANEMARK SYSTEM 3.3MM FIXTURE

K-Number: K944683 · 1995-03-08

ApplicantNobelpharma USA, Inc.
Decision Date1995-03-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRANEMARK SYSTEM 3.3MM 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 1995-03-08 under 510(k) number K944683. 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 3.3MM FIXTURE?

BRANEMARK SYSTEM 3.3MM FIXTURE is a medical device that received FDA 510(k) clearance on 1995-03-08. The listed applicant is Nobelpharma USA, Inc.. The 510(k) number is K944683.

When did BRANEMARK SYSTEM 3.3MM FIXTURE receive FDA 510(k) clearance?

BRANEMARK SYSTEM 3.3MM FIXTURE received FDA 510(k) clearance on 1995-03-08, under 510(k) number K944683.

Who is the listed applicant for BRANEMARK SYSTEM 3.3MM 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 3.3MM FIXTURE?

The FDA product code for BRANEMARK SYSTEM 3.3MM FIXTURE is DZE.

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Other records listing Nobelpharma USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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