Duns Number:244261462
Device Description: COMFORT-SONIC B1, DENTAL ULTRASONIC SCALER, BUILT-IN MODULE
Catalog Number
-
Brand Name
Comfort-Sonic
Version/Model Number
UL3300
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
K053555
Product Code
ELC
Product Code Name
Scaler, Ultrasonic
Public Device Record Key
a55348cd-4213-4cc4-91cf-d651593867b0
Public Version Date
October 14, 2022
Public Version Number
1
DI Record Publish Date
October 06, 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 | 150 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |
| U | Unclassified | 6 |