Duns Number:190377184
Device Description: Universal Film Mounts, Box with White Space
Catalog Number
VP-1000
Brand Name
Plasdent
Version/Model Number
VP-1000
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
Yes
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
NRD
Product Code Name
Unit, Operative Dental, Accessories
Public Device Record Key
84c4be72-794b-41ed-b6b7-5dec057bf69e
Public Version Date
March 30, 2022
Public Version Number
1
DI Record Publish Date
March 22, 2022
Package DI Number
D832VP10002
Quantity per Package
18
Contains DI Package
D832VP10001
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 750 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |