Duns Number:532282466
Device Description: Dental Composite - B1 shade
Catalog Number
-
Brand Name
Infinix Universal Composite
Version/Model Number
INF-UC-PP-MD-B1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K201010,K201010
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
1f5cd66a-e0ef-4836-a11e-a6a4c43e58bf
Public Version Date
March 23, 2021
Public Version Number
1
DI Record Publish Date
March 15, 2021
Package DI Number
17290017528035
Quantity per Package
1
Contains DI Package
07290017528038
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 28 |