Duns Number:005473608
Device Description: GC CROWNTEK™ Refill Size, 5 crowns of one size Cuspid Up R. (3 +.5)
Catalog Number
412106
Brand Name
GC CROWNTEK™
Version/Model Number
412106
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 01, 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
Yes
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
ELZ
Product Code Name
CROWN, PREFORMED
Public Device Record Key
f09a09f8-cec6-48ef-af96-52185876b1a2
Public Version Date
March 10, 2021
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 | 480 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4772 |