Duns Number:005473608
Device Description: UNIFAST™ LC Package contains 1 bottle Powder (30g) shade B2, 2 bottles Liquid (15mL each), UNIFAST™ LC Package contains 1 bottle Powder (30g) shade B2, 2 bottles Liquid (15mL each), 2 rubber cups, Spatula and powder measure
Catalog Number
338012
Brand Name
UNIFAST™
Version/Model Number
338012
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
K890829
Product Code
EBG
Product Code Name
CROWN AND BRIDGE, TEMPORARY, RESIN
Public Device Record Key
b7783275-6438-4895-bb13-646d1640f0c9
Public Version Date
October 29, 2021
Public Version Number
4
DI Record Publish Date
August 01, 2016
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 | 480 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4772 |