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FDA 510(k)

RODO Abutment System

K-Number: K160786 · 2016-11-21

ApplicantRodo Medical, Inc.
Decision Date2016-11-21
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RODO Abutment System 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 2016-11-21 under 510(k) number K160786. 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 Abutment System?

RODO Abutment System is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Rodo Medical, Inc.. The 510(k) number is K160786.

When did RODO Abutment System receive FDA 510(k) clearance?

RODO Abutment System received FDA 510(k) clearance on 2016-11-21, under 510(k) number K160786.

Who is the listed applicant for RODO Abutment System?

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 Abutment System?

The FDA product code for RODO Abutment System 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 SystemK180609Rodo Smilekey

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.

K261147Neodent 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, LLCK260564DESS Dental Smart SolutionsTerrats Medical SL

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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