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510(k) K051267

GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE by W.L. Gore & Associates, Inc. — Product Code NPK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2005
Date Received
May 16, 2005
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 W.L. Gore & Associates, Inc.

  • K250410 — GORE® Tri-Lobe Balloon Catheter (June 2, 2025)
  • K240083 — GORE® PROPATEN® Vascular Graft (March 1, 2024)
  • K232312 — GORE® PROPATEN® Vascular Graft (January 9, 2024)
  • K233551 — GORE® ACUSEAL Vascular Graft (December 19, 2023)
  • K231505 — GORE® ACUSEAL Vascular Graft (June 23, 2023)
  • K191773 — GORE BIO-A Tissue Reinforcement (July 31, 2019)
  • K181940 — GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (August 17, 2018)
  • K173333 — GORE ENFORM Biomaterial (April 5, 2018)
  • K163576 — GORE SYNECOR Preperitoneal Biomaterial (May 11, 2017)
  • K170740 — GORE VIABIL Short Wire Biliary Endoprosthesis (May 8, 2017)

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)