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FDA 510(k)

PROCERA ALLCERAM FUSING MATERIAL

K-Number: K983453 · 1998-11-18

ApplicantNobel Biocare Uas, Inc.
Decision Date1998-11-18
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROCERA ALLCERAM FUSING MATERIAL 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 1998-11-18 under 510(k) number K983453. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROCERA ALLCERAM FUSING MATERIAL?

PROCERA ALLCERAM FUSING MATERIAL is a medical device that received FDA 510(k) clearance on 1998-11-18. The listed applicant is Nobel Biocare Uas, Inc.. The 510(k) number is K983453.

When did PROCERA ALLCERAM FUSING MATERIAL receive FDA 510(k) clearance?

PROCERA ALLCERAM FUSING MATERIAL received FDA 510(k) clearance on 1998-11-18, under 510(k) number K983453.

Who is the listed applicant for PROCERA ALLCERAM FUSING MATERIAL?

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 PROCERA ALLCERAM FUSING MATERIAL?

The FDA product code for PROCERA ALLCERAM FUSING MATERIAL is EIH.

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Other records listing Nobel Biocare Uas, Inc. as applicant

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Related Devices (Code: EIH)

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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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