Duns Number:480082080
Device Description: iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromoto iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Catalog Number
1601075-001
Brand Name
Console iOptima INT 2x MX2
Version/Model Number
1601075-001
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
-
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
EIA
Product Code Name
Unit, operative dental
Public Device Record Key
0331d6cf-d856-435c-a7b8-e78f92c15c3d
Public Version Date
June 25, 2021
Public Version Number
1
DI Record Publish Date
June 17, 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 | 213 |