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510(k) K982865

ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT by Atrix Laboratories, Inc. — Product Code NPK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1998
Date Received
August 13, 1998
Clearance Type
Special
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 Atrix Laboratories, Inc.

  • K994137 — ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH (September 13, 2000)
  • K955838 — ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR) (March 21, 1996)

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)