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Cytoflex Resorb

FDA UDI

Class II (US FDA UDI)

by Unicare Biomedical, Inc.

Identity

Trade Name
Cytoflex Resorb FDA UDI
Generic Name
Pliable-polymer dental regeneration membrane, bioabsorbable, ligated FDA UDI
Device Name
Cytoflex® Resorb is a synthetic, microporous resorbable barrier membrane. Cytoflex® Resorb membranes are designed to enhance the adhesion of host cells, and at the same time provide a favorable environment for neo-vascularization and repopulation of bone cells to regenerate osseous tissue. The flexible barrier membranes are easily adaptable to tissue contours, yet offer sufficient duration to protect the bony defect from the intrusion of bacteria and soft tissue. Composed of synthetic polylactide and polyglycolide copolymers, Cytoflex® Resorb barriers are resorbable and do not require a second retrieval procedure. FDA UDI
Model / Reference
30x40mm FDA UDI
Description
Cytoflex® Resorb is a synthetic, microporous resorbable barrier membrane. Cytoflex® Resorb membranes are designed to enhance the adhesion of host cells, and at the same time provide a favorable environment for neo-vascularization and repopulation of bone cells to regenerate osseous tissue. The flexible barrier membranes are easily adaptable to tissue contours, yet offer sufficient duration to protect the bony defect from the intrusion of bacteria and soft tissue. Composed of synthetic polylactide and polyglycolide copolymers, Cytoflex® Resorb barriers are resorbable and do not require a second retrieval procedure. FDA UDI

Identifiers

Catalog Number
C03-0101 FDA UDI
Primary DI / UDI-DI
D767C0301010 FDA UDI
510(k) Number
K090083 FDA UDI
FDA Product Code
NPK FDA UDI
GMDN Term
Pliable-polymer dental regeneration membrane, bioabsorbable, ligated 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

Yes

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, bioabsorbable, ligated

Cytoflex Resorb 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, bioabsorbable, ligated.

Cleared under the same submission

K090083 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 00f1d4ac-18b0-4640-beb7-f4e1c90d9186 37 fields · synced May 30, 2026