Duns Number:338234588
Device Description: Accessory connects micro-motors to the console or other boards, thus allowing the control Accessory connects micro-motors to the console or other boards, thus allowing the control and functioning of the whole device.
Catalog Number
1600902-001
Brand Name
COUPLING MULTIFLEX 4H L
Version/Model Number
1600902-001
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
f91e5fa6-7aff-441e-a20c-2e28f67ea4bf
Public Version Date
October 26, 2022
Public Version Number
2
DI Record Publish Date
June 17, 2021
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 | 80 |