Cleared Abbreviated

Customized Abutment and Screw

K242768 · Chengdu Besmile Medical Technology Co., Ltd. · Dental

Sep 2025

Decision

354d

Days

Class 2

Risk

About This 510(k) Submission

K242768 is an FDA 510(k) clearance for the Customized Abutment and Screw, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Chengdu Besmile Medical Technology Co., Ltd. (Chengdu, CN). The FDA issued a Cleared decision on September 2, 2025, 354 days after receiving the submission on September 13, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K242768 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 13, 2024
Decision Date	September 02, 2025
Days to Decision	354 days
Submission Type	Abbreviated
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.