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FDA 510(k)

Rodo Smilekey

K-Number: K180609 · 2018-05-23

ApplicantRodo Medical, Inc.
Decision Date2018-05-23
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Rodo Smilekey is a medical device manufactured by Rodo Medical, Inc.. It received FDA 510(k) clearance on 2018-05-23 under approval number K180609. 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 Rodo Smilekey?

Rodo Smilekey is a medical device that received FDA 510(k) clearance on 2018-05-23. It is manufactured by Rodo Medical, Inc.. The 510(k) number is K180609.

When was Rodo Smilekey approved by the FDA?

Rodo Smilekey received FDA 510(k) clearance on 2018-05-23, under approval number K180609.

What company makes Rodo Smilekey?

Rodo Smilekey is manufactured by Rodo Medical, Inc..

What is the FDA product code for Rodo Smilekey?

The FDA product code for Rodo Smilekey is NHA.

Other Devices by Rodo Medical, Inc.

K160786RODO Abutment System K193274Rodo Abutment System

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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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