Duns Number:012430880
Device Description: Essentials MaxPro Handpiece
Catalog Number
1127367
Brand Name
Essentials
Version/Model Number
1127367
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
-
Product Code
EFB
Product Code Name
Handpiece, air-powered, dental
Public Device Record Key
10cd70d1-71f7-4ad6-b516-ecf749091d60
Public Version Date
November 11, 2019
Public Version Number
4
DI Record Publish Date
April 19, 2018
Package DI Number
10304040063528
Quantity per Package
10
Contains DI Package
00304040063521
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |