Duns Number:006309355
Device Description: Athena Champion Head Latch Type 12 Tooth, Angle Head for Contra Angle Handpiece, Low Speed
Catalog Number
44002-12
Brand Name
Athena Champion
Version/Model Number
44002-12
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
K974670,K974670
Product Code
EFB
Product Code Name
Handpiece, air-powered, dental
Public Device Record Key
308c4447-f111-4165-ae83-fe2ddef11a31
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 16, 2022
Package DI Number
10302730001874
Quantity per Package
1
Contains DI Package
00302730001877
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 |