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Cytoflex Mesh

FDA UDI

Class II (US FDA UDI)

by Unicare Biomedical, Inc.

Identity

Trade Name
Cytoflex Mesh FDA UDI
Generic Name
Dental bone matrix implant, metallic FDA UDI
Device Name
Cytoflex® Mesh is made of pure implantable Titanium with a precision mesh profile. This product is designed for use to ensure three-dimensional reconstruction of alveolar bone defects and to facilitate bone augmentation through adequate fixation of the augmentation material. The thin, supple mesh conforms easily to tissue contours, and yet presents sufficient stiffness to maintain space over the bony defect. FDA UDI
Model / Reference
M4-200 FDA UDI
Description
Cytoflex® Mesh is made of pure implantable Titanium with a precision mesh profile. This product is designed for use to ensure three-dimensional reconstruction of alveolar bone defects and to facilitate bone augmentation through adequate fixation of the augmentation material. The thin, supple mesh conforms easily to tissue contours, and yet presents sufficient stiffness to maintain space over the bony defect. FDA UDI

Identifiers

Catalog Number
C02-4201 FDA UDI
Primary DI / UDI-DI
D767C0242010 FDA UDI
510(k) Number
K021511 FDA UDI
FDA Product Code
JEY FDA UDI
GMDN Term
Dental bone matrix implant, metallic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4760 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: Dental bone matrix implant, metallic

Cytoflex Mesh by Unicare Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental bone matrix implant, metallic.

Cleared under the same submission

K021511 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 6429e632-3c75-43ed-9a5e-b2093731feb7 37 fields · synced May 30, 2026