510(k) K974752

IMTEC/BIOBARRIER MEMBRANE by Imtec Corp. — Product Code NPK

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 3, 1998
Date Received: December 19, 1997
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 Imtec Corp.

K081653 — MDI MII ONE-PIECE IMPLANT, 2.9MM (September 19, 2008)
K081347 — ILUMA VISION (May 28, 2008)
K072660 — ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 (December 12, 2007)
K053046 — ILUMA ORTHOCAT/DENTALCAT (November 8, 2005)
K043226 — ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 (January 13, 2005)
K042289 — MDI ORTHO (September 15, 2004)
K033432 — LEXATITE QUICK ACRYLIC (January 15, 2004)
K031106 — IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, M (August 12, 2003)
K030243 — ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 (April 23, 2003)
K024044 — SABER TECH IMPLANTS SYSTEM (February 21, 2003)

Other clearances for product code NPK

K221851 — Lumina-PTFE Titanium (December 8, 2023)
K222549 — OpenTex (May 11, 2023)
K211554 — InnoGenic Non-resorbable Membrane (February 24, 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)