Duns Number:623191194
Device Description: DHPI Health Tec Dispersed Phase Single Spill Regular Set
Catalog Number
100-UPD1500RS
Brand Name
DHPI Health-Tec Dental Amalgam Alloy
Version/Model Number
100-UPD1500RS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2022
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K820617,K820617
Product Code
EJJ
Product Code Name
Alloy, Amalgam
Public Device Record Key
f5c389e3-102c-43e0-bddf-c46f6fbac372
Public Version Date
September 30, 2022
Public Version Number
4
DI Record Publish Date
January 24, 2017
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 |