Home / 510(k) Clearances / K972240

510(k) K972240

IMTEC BIOBARRIER MEMBRANE by Imtec Corp. — Product Code NPK

K972240 is an FDA 510(k) premarket notification submitted by Imtec Corp. for the device "IMTEC BIOBARRIER MEMBRANE". The FDA issued a decision of Substantially Equivalent on August 26, 1997. The device falls under product code NPK (Barrier, Synthetic, Intraoral), a Class II device regulated under 21 CFR 872.3930. Imtec Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1997
Date Received
June 16, 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)

FDA data resources