Duns Number:213136229
Device Description: Infinitas Orthodontic Mini Implant L6mm, D1.5mm Short Neck
Catalog Number
DB10-0001
Brand Name
Infinitas Orthodontic Mini Implant
Version/Model Number
Infinitas M/I L6mm, D1.5mm S/N
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)
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
77738f4c-1535-4e0b-af7d-1b2efb0beb29
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 25, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 10 |