Duns Number:623191194
Device Description: DHP DE Scaler H6-7
Catalog Number
700-DHP110
Brand Name
DHP Scaler Instruments
Version/Model Number
700-DHP110
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EMN
Product Code Name
Scaler, Periodontic
Public Device Record Key
7ee5020d-1e1c-4730-993f-5c222f6cac13
Public Version Date
September 30, 2022
Public Version Number
1
DI Record Publish Date
September 22, 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 | 464 |
2 | A medical device with a moderate to high risk that requires special controls. | 78 |