Cleared Traditional

EK Digital Abutments

K233389 · Hiossen, Inc. · Dental

May 2024

Decision

240d

Days

Class 2

Risk

About This 510(k) Submission

K233389 is an FDA 510(k) clearance for the EK Digital Abutments, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Hiossen, Inc. (Fariless Hills, US). The FDA issued a Cleared decision on May 29, 2024, 240 days after receiving the submission on October 2, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K233389 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 02, 2023
Decision Date	May 29, 2024
Days to Decision	240 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.