Duns Number:038023573
Device Description: Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in gui 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. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE), the textured version of Cytoflex® Tef-Guard® has superficial macro texture overlapping the micro pore texture on both surfaces. The cellular level micro texture is invisible to the naked eye, but can be seen at high magnifications. The macro texture provides additional grips for flap attachment.
Catalog Number
C04-0201
Brand Name
Cytoflex Textured Tef-Guard
Version/Model Number
TEX-200
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K012144,K012144
Product Code
NPK
Product Code Name
Barrier, Synthetic, Intraoral
Public Device Record Key
2cd6d900-56b3-4d32-a190-489e29370d1f
Public Version Date
July 27, 2021
Public Version Number
4
DI Record Publish Date
November 23, 2016
Package DI Number
D767C0402051
Quantity per Package
5
Contains DI Package
D767C0402010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 11 |
U | Unclassified | 1 |