Duns Number:486717338
Device Description: Kneadable base impression material based on addition curing vinyl silicones - Blue, Regula Kneadable base impression material based on addition curing vinyl silicones - Blue, Regular Set
Catalog Number
SEL-SIL-FR-B400
Brand Name
Select Sil Firm Putty
Version/Model Number
SEL-SIL-FR-B400
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
-
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
-
Product Code
ELW
Product Code Name
Material, Impression
Public Device Record Key
6957317f-a02c-4119-8317-c6434dd4ad15
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 05, 2017
Package DI Number
17540208000353
Quantity per Package
1
Contains DI Package
07540208000356
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |