FDA 510(k)

TiGEN Abutment, PMMA Abutment and Scan Healing Abutment

Número K: K234142 · 2024-09-18

Data da decisão2024-09-18

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Megagen Implant Co., Ltd. como candidato(a)

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 K231967Sistema de Implante ExCon ARi

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Fonte oficial

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