Duns Number:315427286
Device Description: Ortho-Cast M-Series 22 Buccal tubes, -20° Torque, 0° Offset for tooth 47-46
Catalog Number
-
Brand Name
N.A.
Version/Model Number
822-122-40
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 06, 2019
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DZD
Product Code Name
TUBE, ORTHODONTIC
Public Device Record Key
9780b34e-5a22-4fd0-99eb-a9d699ce96c4
Public Version Date
February 06, 2019
Public Version Number
3
DI Record Publish Date
September 15, 2016
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. | 1745 |