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FDA 510(k)

Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment

K-Number: K192614 · 2020-02-13

ApplicantMegagen Implant Co., Ltd.
Decision Date2020-02-13
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2020-02-13 under 510(k) number K192614. 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 Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment?

Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is a medical device that received FDA 510(k) clearance on 2020-02-13. The listed applicant is Megagen Implant Co., Ltd.. The 510(k) number is K192614.

When did Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment receive FDA 510(k) clearance?

Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment received FDA 510(k) clearance on 2020-02-13, under 510(k) number K192614.

Who is the listed applicant for Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment?

The FDA 510(k) record lists Megagen Implant Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment?

The FDA product code for Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is NHA.

Other records listing Megagen Implant Co., 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.

K251232MegaGen Zygoma Dental Implant SystemK242030MegaGen Dental Implant AbutmentK241972BLUEDIAMOND IMPLANTK234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentK240754N2K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw

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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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