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FDA 510(k)

Custom Legacy and Custom InterActive Titanium Abutments

K-Number: K192218 · 2020-05-08

ApplicantImplant Direct Sybron Manufacturing, LLC
Decision Date2020-05-08
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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