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FDA 510(k)

ZIRKONZAHN ICE

K-Number: K061851 · 2006-09-29

ApplicantZirkonzahn GmbH
Decision Date2006-09-29
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZIRKONZAHN ICE is the device name listed in this FDA 510(k) record. The listed applicant is Zirkonzahn GmbH. It received FDA 510(k) clearance on 2006-09-29 under 510(k) number K061851. 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 ZIRKONZAHN ICE?

ZIRKONZAHN ICE is a medical device that received FDA 510(k) clearance on 2006-09-29. The listed applicant is Zirkonzahn GmbH. The 510(k) number is K061851.

When did ZIRKONZAHN ICE receive FDA 510(k) clearance?

ZIRKONZAHN ICE received FDA 510(k) clearance on 2006-09-29, under 510(k) number K061851.

Who is the listed applicant for ZIRKONZAHN ICE?

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

What is the FDA product code for ZIRKONZAHN ICE?

The FDA product code for ZIRKONZAHN ICE is EIH.

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Other records listing Zirkonzahn GmbH as applicant

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.

K180562TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT

Related Devices (Code: EIH)

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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