Duns Number:532176000
Device Description: Thermoplastic pellets softens within dip hot water for bite registrations,Anterior bite st Thermoplastic pellets softens within dip hot water for bite registrations,Anterior bite stops,,Custom impression material,Customs impression tray,Bleaching trays,Build walls of impressions,Orthopedic appliances.Color White200gr. net jar
Catalog Number
1032126
Brand Name
BD Impress
Version/Model Number
White 200gr.
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)
-
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
6e6d028c-2755-46f0-9bb6-b0ea0898960c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 14, 2017
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |