FDA 510(k)

TiGEN Abutment, PMMA Abutment and Scan Healing Abutment

Numéro K : K234142 · 2024-09-18

Date de décision2024-09-18

Code produitNHA

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

TiGEN Abutment, PMMA Abutment and Scan Healing 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 2024-09-18 under 510(k) number K234142. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the TiGEN Abutment, PMMA Abutment and Scan Healing Abutment?

TiGEN Abutment, PMMA Abutment and Scan Healing Abutment is a medical device that received FDA 510(k) clearance on 2024-09-18. The listed applicant is Megagen Implant Co., Ltd.. The 510(k) number is K234142.

When did TiGEN Abutment, PMMA Abutment and Scan Healing Abutment receive FDA 510(k) clearance?

TiGEN Abutment, PMMA Abutment and Scan Healing Abutment received FDA 510(k) clearance on 2024-09-18, under 510(k) number K234142.

Who is the listed applicant for TiGEN Abutment, PMMA Abutment and Scan Healing 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 TiGEN Abutment, PMMA Abutment and Scan Healing Abutment?

The FDA product code for TiGEN Abutment, PMMA Abutment and Scan Healing Abutment is NHA.

Essais cliniques associés

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Autres dossiers indiquant Megagen Implant Co., Ltd. en tant que demandeur

K251232MegaGen Zygoma Dental Implant System K242030MegaGen Dental Implant Abutment K241972BLUEDIAMOND IMPLANT K240754N2 K233450MegaGen 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 K231967Système d'implantation ARi ExCon

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Dispositifs connexes (Code : NHA)

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLC 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 AB K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.

Source officielle

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