FDA 510(k)

GPS Angled Abutment

K-Number: K153509 · 2016-08-26

ApplicantImplant Direct Sybron Manufacturing, LLC

Decision Date2016-08-26

Product CodeNHA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

GPS Angled Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K153509. 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 GPS Angled Abutment?

GPS Angled Abutment is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K153509.

When did GPS Angled Abutment receive FDA 510(k) clearance?

GPS Angled Abutment received FDA 510(k) clearance on 2016-08-26, under 510(k) number K153509.

Who is the listed applicant for GPS Angled Abutment?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GPS Angled Abutment?

The FDA product code for GPS Angled Abutment is NHA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.