Duns Number:606173334
Device Description: Contains one (1) 60 gram powder (Pink), one (1) 30 gram powder (Clear), one (1) 60 millili Contains one (1) 60 gram powder (Pink), one (1) 30 gram powder (Clear), one (1) 60 milliliter liquid, and one (1) 30 milliliter sealer
Catalog Number
N811500
Brand Name
PermaSoft®
Version/Model Number
Soft Denture Liner Combination Kit
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 05, 2022
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBI
Product Code Name
RESIN, DENTURE, RELINING, REPAIRING, REBASING
Public Device Record Key
8b8fd45a-9f16-413f-b106-f3571feefb16
Public Version Date
May 06, 2022
Public Version Number
6
DI Record Publish Date
January 31, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 57 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19532 |