Duns Number:300238441
Device Description: Alegra Highspeed Handpiece
Catalog Number
-
Brand Name
TE-97 C LED G M Turbine
Version/Model Number
10059719
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
EFB
Product Code Name
Handpiece, Air-Powered, Dental
Public Device Record Key
05a61815-ad15-4093-a1c5-ddd08a01c53f
Public Version Date
November 22, 2018
Public Version Number
2
DI Record Publish Date
August 30, 2018
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 | 343 |
2 | A medical device with a moderate to high risk that requires special controls. | 87 |