Duns Number:191036107
Device Description: Light Cure Pattern, Modeling and Indexing Resin.
Catalog Number
HIRO
Brand Name
HIRO Light Cure Pattern, Modeling and Indexing Resin
Version/Model Number
One 3 mL Syringe
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
Yes
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
EKO
Product Code Name
Denture Preformed (Partially Prefabricated Denture)
Public Device Record Key
83dfed49-a954-4edf-9989-c13af179e1b2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 09, 2018
Package DI Number
D820HIRO1
Quantity per Package
2
Contains DI Package
D820HIRO0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 15 |