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FDA 510(k)

InterActive SMARTBase Abutments

K-Number: K181359 · 2018-08-15

ApplicantImplant Direct Sybron Manufacturing, LLC
Decision Date2018-08-15
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

InterActive SMARTBase 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 2018-08-15 under 510(k) number K181359. 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 InterActive SMARTBase Abutments?

InterActive SMARTBase Abutments is a medical device that received FDA 510(k) clearance on 2018-08-15. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K181359.

When did InterActive SMARTBase Abutments receive FDA 510(k) clearance?

InterActive SMARTBase Abutments received FDA 510(k) clearance on 2018-08-15, under 510(k) number K181359.

Who is the listed applicant for InterActive SMARTBase 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 InterActive SMARTBase Abutments?

The FDA product code for InterActive SMARTBase Abutments is NHA.

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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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