Duns Number:120580910
Device Description: ADULT RESIN POSTERIOR KIT CONTAINING 1OZ ACRYLIC LIQUID, 1OZ ACRYLIC POWDER AND 24 CROWN S ADULT RESIN POSTERIOR KIT CONTAINING 1OZ ACRYLIC LIQUID, 1OZ ACRYLIC POWDER AND 24 CROWN SHELLS SIZES 1-8
Catalog Number
-
Brand Name
DIRECTCROWN
Version/Model Number
DC2AK
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBG
Product Code Name
Crown And Bridge, Temporary, Resin
Public Device Record Key
49fcb8fd-5266-481b-bde4-b6f2ffc8fe95
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |