Duns Number:185497372
Device Description: NuSmile BioCem Medium Shade 5.0ml (25) Mixing tip (Blue) (2) Canuala Mixing Tip (Brown)
Catalog Number
-
Brand Name
NuSmile BioCem Medium Shade
Version/Model Number
BCK450MD
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 22, 2019
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
-
Product Code
EJK
Product Code Name
Liner, Cavity, Calcium Hydroxide
Public Device Record Key
fb0b4925-9f09-4e20-9774-35edb2cdb418
Public Version Date
June 25, 2021
Public Version Number
2
DI Record Publish Date
August 27, 2018
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 | 1091 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |
| U | Unclassified | 1 |