Duns Number:644778409
Device Description: Resin Artificial Teeth
Catalog Number
REF.N3B3
Brand Name
REF-LINE
Version/Model Number
REF.N3B3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ELM
Product Code Name
Denture, plastic, teeth
Public Device Record Key
4fd631de-cee0-4541-b5ad-a2ad2e55d779
Public Version Date
June 23, 2021
Public Version Number
1
DI Record Publish Date
June 15, 2021
Package DI Number
EPOLREFN3B303
Quantity per Package
1
Contains DI Package
EPOLREFN3B3
Package Discontinue Date
June 15, 2021
Package Status
Not in Commercial Distribution
Package Type
plastic card
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 3891 |