Duns Number:137217043
Device Description: Hydroclone VPS addition cured silicone elastomeric impression material (VPS) meets or exce Hydroclone VPS addition cured silicone elastomeric impression material (VPS) meets or exceeds requirements for Type 1 impression materials specified by the American Dental Association Specification No. 19. Products are available in multiple viscosities (and as a putty) in both tubes and cartridges for use in various impression techniques. Hydroclone VPS is manufactured to preform according to specifications for work and set time at 73°F (23°C). Higher temperatures will decrease the work time and set time. Conversely, lower temperatures will extend work/set times. The shelf life of these materials is two years. Delivery method: two part putty, regular set, mint flavor. SDS and instructions for use available at https://www.scottsdental.com/hydro-clone-vps-putty.html
Catalog Number
104-8015
Brand Name
SCOTT'S VPS PUTTY 2-JARS REG SET MINT
Version/Model Number
104-8015
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
-
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
adc8e7bf-a738-4749-af47-2f6c02ced486
Public Version Date
August 26, 2020
Public Version Number
4
DI Record Publish Date
June 02, 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 | 1050 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |