Duns Number:016853348
Device Description: The AEU-1000BSB-70V dental Implant Motor System with variable-speed footswitch Blue Sky Bi The AEU-1000BSB-70V dental Implant Motor System with variable-speed footswitch Blue Sky Bio is a drive system for instruments and tools used in dentistry for implant procedures.
Catalog Number
-
Brand Name
BlueSkiBio
Version/Model Number
AEU-1000BSB-70V
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 01, 2032
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
-
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
EKX
Product Code Name
Handpiece, Direct Drive, Ac-Powered
Public Device Record Key
145b821b-49ab-42cd-bbae-5ad177a9760b
Public Version Date
July 22, 2022
Public Version Number
1
DI Record Publish Date
July 14, 2022
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 | 21 |