Cleared Traditional

Cytoplast Titanium-Reinforced PTFE Membranes

K201187 · Osteogenics Biomedical, Inc. · Dental

Jan 2021

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K201187 is an FDA 510(k) clearance for the Cytoplast Titanium-Reinforced PTFE Membranes, a Barrier, Synthetic, Intraoral (Class II — Special Controls, product code NPK), submitted by Osteogenics Biomedical, Inc. (Lubbock, US). The FDA issued a Cleared decision on January 23, 2021, 267 days after receiving the submission on May 1, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K201187 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2020
Decision Date	January 23, 2021
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NPK — Barrier, Synthetic, Intraoral
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3930
Definition	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.