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FDA 510(k)

IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE

K-Number: K124008 · 2013-03-29

ApplicantIvoclar Vivadent, Agin
Decision Date2013-03-29
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, Agin. It received FDA 510(k) clearance on 2013-03-29 under 510(k) number K124008. 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 FOR NOBEL BIOCARE?

IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE is a medical device that received FDA 510(k) clearance on 2013-03-29. The listed applicant is Ivoclar Vivadent, Agin. The 510(k) number is K124008.

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

IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE received FDA 510(k) clearance on 2013-03-29, under 510(k) number K124008.

Who is the listed applicant for IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE?

The FDA 510(k) record lists Ivoclar Vivadent, Agin 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 FOR NOBEL BIOCARE?

The FDA product code for IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE is 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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