Duns Number:036623932
Device Description: Dental ultrasonic scaler uses a wide range of very thin tips for a variety of procedures r Dental ultrasonic scaler uses a wide range of very thin tips for a variety of procedures ranging from routine preventative care to severe periodontal cases. Hygiene model.
Catalog Number
-
Brand Name
Piezo Pilot Ultrasonic Scaler
Version/Model Number
402701
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 28, 2021
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
ELC
Product Code Name
Scaler, Ultrasonic
Public Device Record Key
2fd35e27-15cb-4e92-980f-3f444f7fb83e
Public Version Date
February 01, 2021
Public Version Number
2
DI Record Publish Date
August 14, 2018
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 | 316 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 144 |
| U | Unclassified | 36 |