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Cytoflex Mesh

FDA 510(k)

Class II (US FDA 510(k))

510(k) K021511

by Unicare Biomedical, Inc.

Identifiers

510(k) Number
K021511 FDA 510(k)
FDA Product Code
JEY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.4760 FDA 510(k)
Regulation Number
872.4760 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cytoflex Mesh is a titanium mesh device used for three-dimensional reconstruction of alveolar bone defects and to facilitate bone augmentation through adequate fixation of the augmentation material. It is made of pure, implantable titanium with a precision mesh profile. The mesh conforms easily to tissue contours and presents sufficient stiffness to maintain a desired shape.

The Cytoflex Mesh is supplied as a single-use, implantable device. It is classified as a class 2 device with the product code JEY and regulation number 872.4760. The device has been authorized with an FDA 510K clearance. It is intended for use in dental applications, specifically for bone augmentation and reconstruction of alveolar bone defects.

Frequently asked questions

What is the Cytoflex Mesh used for?

The Cytoflex Mesh is used for three-dimensional reconstruction of alveolar bone defects and to facilitate bone augmentation through adequate fixation of the augmentation material.

Is the Cytoflex Mesh a single-use device?

Yes, the Cytoflex Mesh is supplied as a single-use, implantable device.

What material is the Cytoflex Mesh made of?

The Cytoflex Mesh is made of pure, implantable titanium with a precision mesh profile.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cytoflex® Mesh - Precision Titanium Mesh - Unicare Biomedical Inc., Products - Unicare Biomedical Inc., UNICARE BIOMEDICAL INC. C02-4401 Cytoflex Mesh - RevMed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Unicare Biomedical, Inc.

Sources (1)

  • FDA 510(k) K021511 24 fields · synced Sep 26, 2026