Duns Number:021228671
Device Description: Hard Bite Impression Material
Catalog Number
70-1031-CAP0022
Brand Name
Capture
Version/Model Number
70-1031-CAP0022
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
ELW
Product Code Name
Material, Impression
Public Device Record Key
1c2d8c4a-0747-4b86-bd0f-2adf7261d4bd
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 21, 2017
Package DI Number
D745701031CAP00031
Quantity per Package
20
Contains DI Package
D745701031CAP00220
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 510 |
2 | A medical device with a moderate to high risk that requires special controls. | 2971 |
U | Unclassified | 2 |