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FDA 510(k)

IPS E.MAX PRESS - ABUTMENT SOLUTIONS

K-Number: K120053 · 2012-10-18

ApplicantIvoclar Vivadent, AG
Decision Date2012-10-18
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IPS E.MAX PRESS - ABUTMENT SOLUTIONS is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2012-10-18 under 510(k) number K120053. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IPS E.MAX PRESS - ABUTMENT SOLUTIONS?

IPS E.MAX PRESS - ABUTMENT SOLUTIONS is a medical device that received FDA 510(k) clearance on 2012-10-18. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K120053.

When did IPS E.MAX PRESS - ABUTMENT SOLUTIONS receive FDA 510(k) clearance?

IPS E.MAX PRESS - ABUTMENT SOLUTIONS received FDA 510(k) clearance on 2012-10-18, under 510(k) number K120053.

Who is the listed applicant for IPS E.MAX PRESS - ABUTMENT SOLUTIONS?

The FDA 510(k) record lists Ivoclar Vivadent, AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPS E.MAX PRESS - ABUTMENT SOLUTIONS?

The FDA product code for IPS E.MAX PRESS - ABUTMENT SOLUTIONS is NHA.

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Other records listing Ivoclar Vivadent, AG as applicant

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Related Devices (Code: NHA)

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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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