Cleared Traditional

InnoGenic Non-resorbable Membrane

K211554 · Cowellmedi Co., Ltd. · Dental

Feb 2023

Decision

646d

Days

Class 2

Risk

About This 510(k) Submission

K211554 is an FDA 510(k) clearance for the InnoGenic Non-resorbable Membrane, a Barrier, Synthetic, Intraoral (Class II — Special Controls, product code NPK), submitted by Cowellmedi Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on February 24, 2023, 646 days after receiving the submission on May 19, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K211554 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 19, 2021
Decision Date	February 24, 2023
Days to Decision	646 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NPK — Barrier, Synthetic, Intraoral
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3930
Definition	A Synthetic Dental Barrier Is A Synthetic Material Device, Such As Ptfe, Intended To Aid In Guided Tissue And/or Bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials.