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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 the device name listed in this FDA 510(k) record. The listed applicant is Rodo Medical, Inc.. It received FDA 510(k) clearance on 2018-05-23 under 510(k) 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. The listed applicant is Rodo Medical, Inc.. The 510(k) number is K180609.

When did Rodo Smilekey receive FDA 510(k) clearance?

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

Who is the listed applicant for Rodo Smilekey?

The FDA 510(k) record lists Rodo Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rodo Smilekey?

The FDA product code for Rodo Smilekey is NHA.

Other records listing Rodo Medical, Inc. as applicant

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.

K193274Rodo Abutment SystemK160786RODO Abutment System

Related Devices (Code: NHA)

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.

K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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