Duns Number:689515024
Device Description: SM3 complete set - The SM3 is intended for use in dental oral surgery and dental implant. SM3 complete set - The SM3 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.
Catalog Number
-
Brand Name
SM3
Version/Model Number
SM3 120V OPT
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
EBW
Product Code Name
Controller, Foot, Handpiece And Cord
Public Device Record Key
87b8354e-54c7-4edc-b329-9d89094f3f8d
Public Version Date
May 03, 2019
Public Version Number
1
DI Record Publish Date
April 25, 2019
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |