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FDA 510(k)

NDX ABUTMENTS

K-Number: K121117 · 2012-12-14

ApplicantNational Dentex Corp
Decision Date2012-12-14
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NDX ABUTMENTS is the device name listed in this FDA 510(k) record. The listed applicant is National Dentex Corp. It received FDA 510(k) clearance on 2012-12-14 under 510(k) number K121117. 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 NDX ABUTMENTS?

NDX ABUTMENTS is a medical device that received FDA 510(k) clearance on 2012-12-14. The listed applicant is National Dentex Corp. The 510(k) number is K121117.

When did NDX ABUTMENTS receive FDA 510(k) clearance?

NDX ABUTMENTS received FDA 510(k) clearance on 2012-12-14, under 510(k) number K121117.

Who is the listed applicant for NDX ABUTMENTS?

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

What is the FDA product code for NDX ABUTMENTS?

The FDA product code for NDX ABUTMENTS 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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