Duns Number:063005260
Device Description: Intended to be used to fabricate teeth models, which can be used for multiple purposes suc Intended to be used to fabricate teeth models, which can be used for multiple purposes such as: Aligner model, Retainer model, Bleaching Tray model, Wax-Up model, Removable die model, impression tray.
Catalog Number
SRI-0202022
Brand Name
Die and Model 2 Natural
Version/Model Number
SRI-0202022
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
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
EBH
Product Code Name
Material, Impression Tray, Resin
Public Device Record Key
7ee76e2e-161d-4b9d-aa21-b5dfccc21979
Public Version Date
March 08, 2022
Public Version Number
1
DI Record Publish Date
February 28, 2022
Package DI Number
10850039704137
Quantity per Package
1
Contains DI Package
00850039704130
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |