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FDA 510(k)

CERAMIC(TM) ABUTMENT

K-Number: K913255 · 1994-08-05

ApplicantCeramic Core Corp.
Decision Date1994-08-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERAMIC(TM) ABUTMENT is the device name listed in this FDA 510(k) record. The listed applicant is Ceramic Core Corp.. It received FDA 510(k) clearance on 1994-08-05 under 510(k) number K913255. 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 CERAMIC(TM) ABUTMENT?

CERAMIC(TM) ABUTMENT is a medical device that received FDA 510(k) clearance on 1994-08-05. The listed applicant is Ceramic Core Corp.. The 510(k) number is K913255.

When did CERAMIC(TM) ABUTMENT receive FDA 510(k) clearance?

CERAMIC(TM) ABUTMENT received FDA 510(k) clearance on 1994-08-05, under 510(k) number K913255.

Who is the listed applicant for CERAMIC(TM) ABUTMENT?

The FDA 510(k) record lists Ceramic Core Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CERAMIC(TM) ABUTMENT?

The FDA product code for CERAMIC(TM) ABUTMENT is DZE.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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