Duns Number:320744915
Device Description: Impression material, heavy-bodied consistency and light-bodied consistency. Impressions ma Impression material, heavy-bodied consistency and light-bodied consistency. Impressions made your way. Content: 2 cartridges Honigum Pro Heavy Quad Fast @ 50 ml paste, 1 cartridge Honigum Pro Light Quad Fast@ 50 ml paste , Accessories
Catalog Number
989502
Brand Name
Honigum Pro Trail Kit Fast
Version/Model Number
989502
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K000878
Product Code
ELW
Product Code Name
Material, Impression
Public Device Record Key
06e21448-9144-4f18-ac92-c5eb276abeb1
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 18, 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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 143 |