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FDA 510(k)

PROCERA ALL-CERAMIC PORCELAIN

K-Number: K944702 · 1994-12-02

ApplicantNobelpharma USA, Inc.
Decision Date1994-12-02
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROCERA ALL-CERAMIC PORCELAIN 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 1994-12-02 under 510(k) number K944702. 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 ALL-CERAMIC PORCELAIN?

PROCERA ALL-CERAMIC PORCELAIN is a medical device that received FDA 510(k) clearance on 1994-12-02. The listed applicant is Nobelpharma USA, Inc.. The 510(k) number is K944702.

When did PROCERA ALL-CERAMIC PORCELAIN receive FDA 510(k) clearance?

PROCERA ALL-CERAMIC PORCELAIN received FDA 510(k) clearance on 1994-12-02, under 510(k) number K944702.

Who is the listed applicant for PROCERA ALL-CERAMIC PORCELAIN?

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 PROCERA ALL-CERAMIC PORCELAIN?

The FDA product code for PROCERA ALL-CERAMIC PORCELAIN is EIH.

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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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