510(k) K211554

InnoGenic Non-resorbable Membrane by Cowellmedi Co., Ltd. — Product Code NPK

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 24, 2023
Date Received: May 19, 2021
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Barrier, Synthetic, Intraoral
Device Class: Class II
Regulation Number: 872.3930
Review Panel: DE
Submission Type

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.

Other clearances by Cowellmedi Co., Ltd.

K242287 — SFIT Abutment (September 16, 2025)
K241127 — INNO SLA Mini Plus® Implant System (December 27, 2024)
K231411 — INNO SLA Submerged Hybrid Ti-Base System (December 20, 2023)
K232546 — Meta G UCLA Abutment (November 21, 2023)
K231395 — INNO SLA Submerged Narrow Implant System (October 18, 2023)
K201323 — INNO SLA Submerged Implant System (January 25, 2022)
K132242 — INNO SLA SUBMERGED IMPLANT SYSTEM (December 6, 2013)
K100850 — COWELL IMPLANT SYSTEM (December 20, 2010)
K090054 — ATLAS IMPLANT SYSTEM - WIDE PLUS (July 29, 2009)
K090049 — ATLAS IMPLANT SYSTEM- MINI PLUS (April 20, 2009)

Other clearances for product code NPK

K221851 — Lumina-PTFE Titanium (December 8, 2023)
K222549 — OpenTex (May 11, 2023)
K210797 — Bio-MEM Ti Reinforced Membrane (August 18, 2022)
K201187 — Cytoplast Titanium-Reinforced PTFE Membranes (January 23, 2021)
K171774 — RPM Reinforced PTFE Mesh (October 19, 2017)
K160493 — Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE (September 8, 2016)
K151344 — Cytoflex Tefguard Ti-Enforced Membrane (November 19, 2015)
K143327 — Neoss Ti Reinforced Membrane (April 13, 2015)
K132325 — GUIDOR BIORESORBABLE MATRIX BARRIER (October 29, 2013)
K102184 — MEDPOR CONTAIN CAN IMPLANT (January 7, 2011)