Home / 510(k) Clearances / K160493

510(k) K160493

Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm by Salvin Dental Specialties — Product Code NPK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2016
Date Received
February 22, 2016
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 Salvin Dental Specialties

  • K161857 — Salvin Tenting Screw System (April 28, 2017)
  • K100182 — SALVIN DENTAL SPECIALTIES FIXATION SCREW (May 10, 2010)
  • K073342 — SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW (March 26, 2008)

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)
  • 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)