FDA 510(k)

Custom Legacy and Custom InterActive Titanium Abutments

K-Nummer: K192218 · 2020-05-08

AntragstellerImplant Direct Sybron Manufacturing, LLC

Entscheidungsdatum2020-05-08

ProduktcodeNHA

BeratungsausschussDE

EntscheidungSubstantially Equivalent

Produktübersicht

Custom Legacy and Custom InterActive Titanium Abutments 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 2020-05-08 under 510(k) number K192218. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Custom Legacy and Custom InterActive Titanium Abutments?

Custom Legacy and Custom InterActive Titanium Abutments is a medical device that received FDA 510(k) clearance on 2020-05-08. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K192218.

When did Custom Legacy and Custom InterActive Titanium Abutments receive FDA 510(k) clearance?

Custom Legacy and Custom InterActive Titanium Abutments received FDA 510(k) clearance on 2020-05-08, under 510(k) number K192218.

Who is the listed applicant for Custom Legacy and Custom InterActive Titanium Abutments?

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 Custom Legacy and Custom InterActive Titanium Abutments?

The FDA product code for Custom Legacy and Custom InterActive Titanium Abutments is NHA.

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Offizielle Quelle

In der FDA-Datenbank anzeigen →

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