Duns Number:388000846
Device Description: Our classical bite registration material, fast, hard and precise. Very good cutting and mi Our classical bite registration material, fast, hard and precise. Very good cutting and milling characteristics.8 x 50 ml double cartridges.
Catalog Number
D504875
Brand Name
Regofix opak
Version/Model Number
1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 22, 2018
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K053427
Product Code
ELW
Product Code Name
Material, Impression
Public Device Record Key
9df80f56-6678-4b77-b1d7-3c24bb0b708e
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
February 10, 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 | 129 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |