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Cytoflex Ti-enforced

FDA UDI

Class II (US FDA UDI)

by Unicare Biomedical, Inc.

Identity

Trade Name
Cytoflex Ti-enforced FDA UDI
Generic Name
Pliable-polymer dental regeneration membrane, non-bioabsorbable FDA UDI
Device Name
Ti-Enforced® ePTFE membranes are a multi-layer, non-resorbable membrane intended to be surgically placed under the muco-periosteum to aid in tissue regeneration in accordance with the guided tissue regeneration principle. It is a barrier material with a titanium frame enclosed within two layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft movement during wound healing. The membranes are designed to block bacteria penetration, and impede the migration and establishment of gingival tissue derived cells into bony defects. This provides a more favorable environment for neovascularization and for bone derived cells to repopulate and repair the defect. The Ti-Enforced® membranes are textured on both surfaces to improve handling and adhesion between tissue and membrane. FDA UDI
Model / Reference
25x30mm FDA UDI
Description
Ti-Enforced® ePTFE membranes are a multi-layer, non-resorbable membrane intended to be surgically placed under the muco-periosteum to aid in tissue regeneration in accordance with the guided tissue regeneration principle. It is a barrier material with a titanium frame enclosed within two layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft movement during wound healing. The membranes are designed to block bacteria penetration, and impede the migration and establishment of gingival tissue derived cells into bony defects. This provides a more favorable environment for neovascularization and for bone derived cells to repopulate and repair the defect. The Ti-Enforced® membranes are textured on both surfaces to improve handling and adhesion between tissue and membrane. FDA UDI

Identifiers

Catalog Number
C05-1701 FDA UDI
Primary DI / UDI-DI
D767C0517010 FDA UDI
510(k) Number
K151344 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Cytoflex Ti-enforced 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

K151344 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 229a45c6-7236-4b3e-ba51-54f9fa93e66b 38 fields · synced Jun 1, 2026