Duns Number:691622872
Device Description: "This product can be used to make a very aesthetic retainer called ""Q.C.M. Retainer"".The "This product can be used to make a very aesthetic retainer called ""Q.C.M. Retainer"".The Q.C.M.Retainer is not only crystal clear, but also has a 3 mm width of the plastic resin part, which is excellent for maintaining torque. Furthermore, it can be made with a very simple operation."
Catalog Number
-
Brand Name
Q.C.M.Retainer Wire
Version/Model Number
RWL-P36
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
DZC
Product Code Name
Wire, Orthodontic
Public Device Record Key
8f1d49b0-a385-4328-8872-1c81502ad36e
Public Version Date
August 23, 2021
Public Version Number
1
DI Record Publish Date
August 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 | 13 |