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510(k) K222549

OpenTex by Purgo Biologics, Inc. — Product Code NPK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2023
Date Received
August 23, 2022
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 Purgo Biologics, Inc.

  • K230305 — THE Graft Collagen (July 24, 2024)
  • K230091 — THE Cover (October 6, 2023)
  • K191737 — The Graft Bone Substitute (February 14, 2020)
  • K180992 — Biotex (July 16, 2019)
  • K173188 — The Graft Natural Bone Substitute (July 20, 2018)

Other clearances for product code NPK

  • K221851 — Lumina-PTFE Titanium (December 8, 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)
  • K102184 — MEDPOR CONTAIN CAN IMPLANT (January 7, 2011)