Duns Number:316074384
Device Description: The device is intended to provide a fix anchorage point for attachment of orthodontic appl The device is intended to provide a fix anchorage point for attachment of orthodontic appliance to facilitate the orthodontic movement of the teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
Catalog Number
1201A2308
Brand Name
OrthoEasy
Version/Model Number
1201A2308
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"
-
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
OAT
Product Code Name
Implant, Endosseous, Orthodontic
Public Device Record Key
793ddf98-21b2-49f4-9ae2-ddcfd0b457b8
Public Version Date
October 31, 2018
Public Version Number
3
DI Record Publish Date
September 16, 2015
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 | 5082 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 941 |