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510(k) K143327

Neoss Ti Reinforced Membrane by Neoss, Ltd. — Product Code NPK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2015
Date Received
November 20, 2014
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 Neoss, Ltd.

  • K211396 — Neoss Individual Prosthetics (May 17, 2022)
  • K150669 — Neoss TiBase, Neoss CoCr Abutments (Mono and Multi) (October 8, 2015)
  • K113376 — NEOSS PROACTIVE TAPERED IMPLANT (September 5, 2012)
  • K090452 — NEOSS IMPLANT SYSTEM 03.25 (May 22, 2009)
  • K081851 — NEOSS ACCESS ABUTMENTS (March 2, 2009)
  • K083561 — NEOSS PROACTIVE IMPLANT (February 11, 2009)
  • K071838 — NEOSS VARIOUS TITANIUM ABUTMENTS (October 19, 2007)
  • K043195 — NEO IMPLANT SYSTEM (March 7, 2005)

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)
  • K132325 — GUIDOR BIORESORBABLE MATRIX BARRIER (October 29, 2013)
  • K102184 — MEDPOR CONTAIN CAN IMPLANT (January 7, 2011)