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FDA 510(k)

HERACERAM ZIRKONIA

K-Number: K052543 · 2005-10-25

ApplicantHeraeus Kulzer, Inc.
Decision Date2005-10-25
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HERACERAM ZIRKONIA is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 2005-10-25 under 510(k) number K052543. 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 HERACERAM ZIRKONIA?

HERACERAM ZIRKONIA is a medical device that received FDA 510(k) clearance on 2005-10-25. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K052543.

When did HERACERAM ZIRKONIA receive FDA 510(k) clearance?

HERACERAM ZIRKONIA received FDA 510(k) clearance on 2005-10-25, under 510(k) number K052543.

Who is the listed applicant for HERACERAM ZIRKONIA?

The FDA 510(k) record lists Heraeus Kulzer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HERACERAM ZIRKONIA?

The FDA product code for HERACERAM ZIRKONIA is EIH.

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Other records listing Heraeus Kulzer, 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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