Cleared Traditional

Healing Abutment System

K251434 · Osstem Implant Co., Ltd. · Dental

Mar 2026

Decision

300d

Days

Class 2

Risk

About This 510(k) Submission

K251434 is an FDA 510(k) clearance for the Healing Abutment System, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Osstem Implant Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on March 4, 2026, 300 days after receiving the submission on May 8, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K251434 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2025
Decision Date	March 04, 2026
Days to Decision	300 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NHA — Abutment, Implant, Dental, Endosseous
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3630
Definition	To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.