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FDA 510(k)

Legacy SMARTBase Abutments

K-Number: K191458 · 2019-10-10

ApplicantImplant Direct Sybron Manufacturing, LLC
Decision Date2019-10-10
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Legacy SMARTBase Abutments is a medical device manufactured by Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2019-10-10 under approval number K191458. 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 Legacy SMARTBase Abutments?

Legacy SMARTBase Abutments is a medical device that received FDA 510(k) clearance on 2019-10-10. It is manufactured by Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K191458.

When was Legacy SMARTBase Abutments approved by the FDA?

Legacy SMARTBase Abutments received FDA 510(k) clearance on 2019-10-10, under approval number K191458.

What company makes Legacy SMARTBase Abutments?

Legacy SMARTBase Abutments is manufactured by Implant Direct Sybron Manufacturing, LLC.

What is the FDA product code for Legacy SMARTBase Abutments?

The FDA product code for Legacy SMARTBase 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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