Cleared Traditional

K201187 - Cytoplast Titanium-Reinforced PTFE Memb...

K201187 is an FDA 510(k) clearance for Cytoplast Titanium-Reinforced PTFE Memb..., manufactured by Osteogenics Biomedical, Inc.. The device is a Class 2 Dental device with product code NPK cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K201187 · Osteogenics Biomedical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2021
Decision
267d
Days
Class 2
Risk

K201187 is an FDA 510(k) clearance for the Cytoplast Titanium-Reinforced PTFE Membranes. Classified as Barrier, Synthetic, Intraoral (product code NPK), Class II - Special Controls.

Submitted by Osteogenics Biomedical, Inc. (Lubbock, US). The FDA issued a Cleared decision on January 23, 2021 after a review of 267 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Osteogenics Biomedical, Inc. devices

FDA 510(k) Submission Details - K201187

510(k) Number K201187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 127d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NPK Device Classification - Class 2, Special Controls

Product Code NPK Barrier, Synthetic, Intraoral
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NPK Barrier, Synthetic, Intraoral

All 14
Devices cleared under the same product code (NPK) and FDA review panel - the closest regulatory comparables to K201187.
OpenTex
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InnoGenic Non-resorbable Membrane
K211554 · Cowellmedi Co., Ltd. · Feb 2023
Bio-MEM Ti Reinforced Membrane
K210797 · B&Medi Co., Ltd. · Aug 2022
STRAUMANN MEMBRAGEL
K082111 · Institut Straumann AG · May 2009
GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE
K051267 · W.L. Gore & Associates, Inc. · Jun 2005
INION GTR BIODEGRADABLE MEMBRANE SYSTEM
K033074 · Inion , Ltd. · Mar 2004