TiGEN Abutment, PMMA Abutment and Scan Healing Abutment

FDA 510(k) K234142 · Megagen Implant Co., Ltd.

Substantially Equivalent

510(k) numberK234142

Submission

Device name
TiGEN Abutment, PMMA Abutment and Scan Healing Abutment
Applicant
Megagen Implant Co., Ltd.
Deagu, KR
Received
December 29, 2023
Decision date
September 18, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NHA – Abutment, Implant, Dental, Endosseous
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3630
Specialty
Dental
Implant
Yes

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

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K260564DESS Dental Smart SolutionsNHA · Traditional Terrats Medical SL06/09/2026SE
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More from Hiossen, Inc.

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K251232MegaGen Zygoma Dental Implant SystemDZE · Traditional 06/18/2026SE
K242030MegaGen Dental Implant AbutmentNHA · Traditional 01/13/2025SE
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K240754N2EIA · Special 03/21/2024SE
K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary…NHA · Traditional 01/22/2024SE
K231967ARi ExCon Implant SystemDZE · Traditional 12/07/2023SE
K223909R2GATE Lite TMLLZ · Traditional 10/20/2023SE
K230618MegaGen Dental Implant Systems Portfolio - MR ConditionalDZE · Traditional 10/11/2023SE
K223339Bone Chamber ImplantDZE · Traditional 07/18/2023SE
K211556N2EIA · Traditional 04/05/2023SE

Questions and answers

When was TiGEN Abutment, PMMA Abutment and Scan Healing Abutment cleared by the FDA?

TiGEN Abutment, PMMA Abutment and Scan Healing Abutment (K234142) received a 510(k) decision of Substantially Equivalent on September 18, 2024, 264 days after the submission was received.

What is the product code of K234142?

The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.