Duns Number:190377184
Device Description: Low Speed Contra-Angle Cover, 8"L, 3 1/2" Opening
Catalog Number
PS710
Brand Name
Plasdent
Version/Model Number
PS710
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
K201604,K201604,K201604
Product Code
PEM
Product Code Name
Dental Barriers And Sleeves
Public Device Record Key
eadd5258-f283-49d6-8db3-1237ee481374
Public Version Date
July 08, 2022
Public Version Number
1
DI Record Publish Date
June 30, 2022
Package DI Number
D832PS7102
Quantity per Package
20
Contains DI Package
D832PS7101
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 |