Cleared Traditional

K151344 - Cytoflex Tefguard Ti-Enforced Membrane

K151344 is an FDA 510(k) clearance for Cytoflex Tefguard Ti-Enforced Membrane, manufactured by Unicare Biomedical, Inc.. The device is a Class 2 Dental device with product code NPK cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K151344 · Unicare Biomedical, Inc. · Dental device
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Nov 2015
Decision
184d
Days
Class 2
Risk

K151344 is an FDA 510(k) clearance for the Cytoflex Tefguard Ti-Enforced Membrane. Classified as Barrier, Synthetic, Intraoral (product code NPK), Class II - Special Controls.

Submitted by Unicare Biomedical, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on November 19, 2015 after a review of 184 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 Unicare Biomedical, Inc. devices

FDA 510(k) Submission Details - K151344

510(k) Number K151344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2015
Decision Date November 19, 2015
Days to Decision 184 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 127d · This submission: 184d
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 17
Devices cleared under the same product code (NPK) and FDA review panel - the closest regulatory comparables to K151344.
InnoGenic Non-resorbable Membrane
K211554 · Cowellmedi Co., Ltd. · Feb 2023
Bio-MEM Ti Reinforced Membrane
K210797 · B&Medi Co., Ltd. · Aug 2022
Cytoplast Titanium-Reinforced PTFE Membranes
K201187 · Osteogenics Biomedical, Inc. · Jan 2021
MEDPOR CONTAIN CAN IMPLANT
K102184 · Porex Surgical, Inc. · Jan 2011
MEDPOR CONTAIN IMPLANT
K091120 · Porex Surgical, Inc. · Mar 2010
STRAUMANN MEMBRAGEL
K082111 · Institut Straumann AG · May 2009