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Cytoflex Smooth Tef-Guard

FDA UDI

Class II (US FDA UDI)

by Unicare Biomedical, Inc.

Identity

Trade Name
Cytoflex Smooth Tef-Guard FDA UDI
Generic Name
Pliable-polymer dental regeneration membrane, non-bioabsorbable FDA UDI
Device Name
Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE) thin film, Cytoflex® Tef-Guard® has a surface texture and porosity suitable for adhesion of host cells to the material while blocking passage and integration of bacteria within the interstices of the material. The supple membrane conforms easily to tissue contours, and yet offers sufficient stiffness to maintain a space over the bony defect. The micro porous surface is designed to improve flap attachment but prevent tissue and bacteria ingrowth. Cytoflex® Tef-Guard® is for use as a barrier membrane for guided tissue regeneration procedures. The cellular level micro texture is invisible to the naked eye, but can be seen at high magnifications. FDA UDI
Model / Reference
TEF-001 FDA UDI
Description
Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE) thin film, Cytoflex® Tef-Guard® has a surface texture and porosity suitable for adhesion of host cells to the material while blocking passage and integration of bacteria within the interstices of the material. The supple membrane conforms easily to tissue contours, and yet offers sufficient stiffness to maintain a space over the bony defect. The micro porous surface is designed to improve flap attachment but prevent tissue and bacteria ingrowth. Cytoflex® Tef-Guard® is for use as a barrier membrane for guided tissue regeneration procedures. The cellular level micro texture is invisible to the naked eye, but can be seen at high magnifications. FDA UDI

Identifiers

Catalog Number
C01-0301 FDA UDI
Primary DI / UDI-DI
D767C0103010 FDA UDI
510(k) Number
K012144 FDA UDI
FDA Product Code
NPK FDA UDI
GMDN Term
Pliable-polymer dental regeneration membrane, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3930 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pliable-polymer dental regeneration membrane, non-bioabsorbable

Cytoflex Smooth Tef-Guard by Unicare Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pliable-polymer dental regeneration membrane, non-bioabsorbable.

Cleared under the same submission

K012144 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Unicare Biomedical, Inc.

Sources (1)

  • FDA UDI e0f7b8cf-db5b-437f-8f5c-22d2d37d8ee5 37 fields · synced Jun 6, 2026