Duns Number:081305064
Device Description: RUBBER DAM CLAMPS KIT WITH 12 DAM PLATE..(0 1 2 2S 4 5 8A 12A 13A 9S 56 212) ..
Catalog Number
N7246N
Brand Name
Power Dental U.S.A., Inc.
Version/Model Number
N7246N
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"
Yes
For Single-Use
-
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
EEF
Product Code Name
CLAMP, RUBBER DAM
Public Device Record Key
902ad6c6-eea3-483f-937f-6571a191b70a
Public Version Date
July 21, 2021
Public Version Number
1
DI Record Publish Date
July 13, 2021
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 | 2768 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |