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FDA 510(k)

BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE)

K-Number: K953775 · 1995-09-21

ApplicantNobelpharma USA, Inc.
Decision Date1995-09-21
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE) 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 1995-09-21 under 510(k) number K953775. 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 BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE)?

BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE) is a medical device that received FDA 510(k) clearance on 1995-09-21. The listed applicant is Nobelpharma USA, Inc.. The 510(k) number is K953775.

When did BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE) receive FDA 510(k) clearance?

BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE) received FDA 510(k) clearance on 1995-09-21, under 510(k) number K953775.

Who is the listed applicant for BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE)?

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 BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE)?

The FDA product code for BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE) is DZE.

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Other records listing Nobelpharma USA, Inc. as applicant

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Related Devices (Code: DZE)

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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