Duns Number:006309355
Device Description: Athena Champion Little Guy Handpiece, Low Speed, 4 Hole Connector, Reversible
Catalog Number
55400
Brand Name
Athena Champion
Version/Model Number
55400
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
-
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
K974671,K974671
Product Code
EFB
Product Code Name
Handpiece, air-powered, dental
Public Device Record Key
f39c1578-e200-42df-89c2-e0e32ae5b682
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 16, 2022
Package DI Number
10302730002017
Quantity per Package
1
Contains DI Package
00302730002010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 138 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85 |