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FDA 510(k)

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments

K-Number: K182228 · 2019-01-28

ApplicantMis Implants Technologies , Ltd.
Decision Date2019-01-28
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments is the device name listed in this FDA 510(k) record. The listed applicant is Mis Implants Technologies , Ltd.. It received FDA 510(k) clearance on 2019-01-28 under 510(k) number K182228. 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 MIS LOCKiT Abutments System, OT-Equators and Ball Attachments?

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments is a medical device that received FDA 510(k) clearance on 2019-01-28. The listed applicant is Mis Implants Technologies , Ltd.. The 510(k) number is K182228.

When did MIS LOCKiT Abutments System, OT-Equators and Ball Attachments receive FDA 510(k) clearance?

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments received FDA 510(k) clearance on 2019-01-28, under 510(k) number K182228.

Who is the listed applicant for MIS LOCKiT Abutments System, OT-Equators and Ball Attachments?

The FDA 510(k) record lists Mis Implants Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIS LOCKiT Abutments System, OT-Equators and Ball Attachments?

The FDA product code for MIS LOCKiT Abutments System, OT-Equators and Ball Attachments is NHA.

Other records listing Mis Implants Technologies , Ltd. 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.

K180282MIS Internal Hex Dental Implant SystemK173326MIS CONNECT Conical Connection AbutmentK172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection AbutmentsK163349MIS V3 Conical Connection Dental Implant 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

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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