Duns Number:480082080
Device Description: Maintenance products (cleaning the device and lubricate the active parts as ball bearings) Maintenance products (cleaning the device and lubricate the active parts as ball bearings)are intended for use in dentistry by professional users, to maintain the proper and safe functioning of the dental instruments
Catalog Number
1600617-001
Brand Name
Maint Aquacare (Single Can)
Version/Model Number
1600617-001
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
730a9ac3-a17a-487b-b25f-aff6afe4e085
Public Version Date
July 02, 2021
Public Version Number
3
DI Record Publish Date
June 17, 2021
Package DI Number
J00716006170061
Quantity per Package
6
Contains DI Package
J00716006170011
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box 6 Cans
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 213 |