Cleared Traditional

Bio-MEM Ti Reinforced Membrane

K210797 · B&Medi Co., Ltd. · Dental

Aug 2022

Decision

520d

Days

Class 2

Risk

About This 510(k) Submission

K210797 is an FDA 510(k) clearance for the Bio-MEM Ti Reinforced Membrane, a Barrier, Synthetic, Intraoral (Class II — Special Controls, product code NPK), submitted by B&Medi Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on August 18, 2022, 520 days after receiving the submission on March 16, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K210797 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 16, 2021
Decision Date	August 18, 2022
Days to Decision	520 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.