Duns Number:255407272
Device Description: Sable - NSK Type Doctor's Push Button Ball Bearing Latch Head Package.Package Contains: Ai Sable - NSK Type Doctor's Push Button Ball Bearing Latch Head Package.Package Contains: Air motor (1600110), 1:1 Contra Angle (1600210), 1:1 Nosecone (1600310), Push-Button Latch Head (1600421)
Catalog Number
-
Brand Name
SABLE - Doctor's Package
Version/Model Number
1600009
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
K083101
Product Code
EFB
Product Code Name
Handpiece, Air-Powered, Dental
Public Device Record Key
36f07b48-4a3f-473e-9572-8a5c06544a1f
Public Version Date
August 08, 2022
Public Version Number
1
DI Record Publish Date
July 29, 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 | 72 |