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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 a medical device manufactured by Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2020-05-08 under approval 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. It is manufactured by Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K192218.

When was Custom Legacy and Custom InterActive Titanium Abutments approved by the FDA?

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

What company makes Custom Legacy and Custom InterActive Titanium Abutments?

Custom Legacy and Custom InterActive Titanium Abutments is manufactured by Implant Direct Sybron Manufacturing, LLC.

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.

Other Devices by Implant Direct Sybron Manufacturing, LLC

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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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