Duns Number:005432299
Device Description: UL 2nd Molar W/Distal Extension Torque -14, Tip 0, Distal Offset 14 UL 2nd Molar W/Distal Extension Torque -14, Tip 0, Distal Offset 14 0.46 mm 0.64 mm (.018"x .025") 4.0 mm
Catalog Number
-
Brand Name
Second Molar Single Tube W/Vertical Slot
Version/Model Number
391-128
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
ECN
Product Code Name
CLAMP, WIRE, ORTHODONTIC
Public Device Record Key
f721cb33-e735-4846-b378-b4cc38230ccf
Public Version Date
October 29, 2021
Public Version Number
2
DI Record Publish Date
March 15, 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 | 2591 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 715 |