Duns Number:204137145
Device Description: Dental impression material to reproduce the structure of a patient's teeth and gums. Packa Dental impression material to reproduce the structure of a patient's teeth and gums. Packaged in a cartridge system. Monophase, regular set.
Catalog Number
SH-104
Brand Name
Polysil Multipurpose Regular Set
Version/Model Number
SH-104
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
ad4587cb-388b-4258-a0b9-c754c670fe10
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 02, 2016
Package DI Number
17540196000540
Quantity per Package
2
Contains DI Package
07540196000543
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 114 |