Duns Number:687796909
Device Description: Instradent Membrane is made from pure Type I porcine collagen membrane. It is a resorbable Instradent Membrane is made from pure Type I porcine collagen membrane. It is a resorbable collagen membrane for guided tissue and bone regenerations. The Type I collagen is obtained from porcine skin purified to avoid immunological reactions. The Instradent Membrane membrane is manufactured by fibrillogenesis and glycation with sugar (ribose). The collagen fibers are self-assembled by the process of fibrillogenesis. The glycation is a natural process of cross-linking of collagen occurring in vivo. The glycated collagen fibers exhibit increased mechanical strength, thermal stability and increased resistance to pepsin digestion compared to non-glycated collagen.
Catalog Number
-
Brand Name
Instradent Membrane
Version/Model Number
IGDS 2-3025
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K133507
Product Code
NPL
Product Code Name
Barrier, Animal Source, Intraoral
Public Device Record Key
825c6978-b9e4-4151-b1b2-2dde9a490984
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 102 |