Duns Number:081305064
Device Description: ORTHODONTIC PLIER BIRD BEAK WITH SOFT WIRE CUTTER (3 GROOVE)
Catalog Number
N5718J3
Brand Name
Power Dental U.S.A., Inc.
Version/Model Number
N5718J3
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
JEX
Product Code Name
PLIER, ORTHODONTIC
Public Device Record Key
9c8c3319-d394-451d-bfd3-4f27974e9181
Public Version Date
June 28, 2021
Public Version Number
1
DI Record Publish Date
June 20, 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 |