Cleared Traditional

K151344 - Cytoflex Tefguard Ti-Enforced Membrane (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 30
Devices cleared under the same product code (NPK) and FDA review panel - the closest regulatory comparables to K151344.
Lumina-PTFE Titanium
K221851 · Criteria Industria E Comercio DE Produtos Medicinais · Dec 2023
OpenTex
K222549 · Purgo Biologics, Inc. · May 2023
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