Cleared Traditional

INNO SLA Submerged Hybrid Ti-Base System

K231411 · Cowellmedi Co., Ltd. · Dental

Dec 2023

Decision

218d

Days

Class 2

Risk

About This 510(k) Submission

K231411 is an FDA 510(k) clearance for the INNO SLA Submerged Hybrid Ti-Base System, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Cowellmedi Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on December 20, 2023, 218 days after receiving the submission on May 16, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K231411 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2023
Decision Date	December 20, 2023
Days to Decision	218 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.