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FDA 510(k)

OT EQUATOR

K-Number: K160382 · 2016-08-11

ApplicantRhein'83 Srl
Decision Date2016-08-11
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OT EQUATOR is the device name listed in this FDA 510(k) record. The listed applicant is Rhein'83 Srl. It received FDA 510(k) clearance on 2016-08-11 under 510(k) number K160382. 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 OT EQUATOR?

OT EQUATOR is a medical device that received FDA 510(k) clearance on 2016-08-11. The listed applicant is Rhein'83 Srl. The 510(k) number is K160382.

When did OT EQUATOR receive FDA 510(k) clearance?

OT EQUATOR received FDA 510(k) clearance on 2016-08-11, under 510(k) number K160382.

Who is the listed applicant for OT EQUATOR?

The FDA 510(k) record lists Rhein'83 Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OT EQUATOR?

The FDA product code for OT EQUATOR is NHA.

Other records listing Rhein'83 Srl 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.

K171409OT EQUATOR

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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