Duns Number:005473608
Device Description: GC Initial™ AL Basic Set, AL Liner 6, Dentin 16, Opaqus Dentin Modifier 2, Enamel 4, Ename GC Initial™ AL Basic Set, AL Liner 6, Dentin 16, Opaqus Dentin Modifier 2, Enamel 4, Enamel Intensive 4, Clear Fluorescence 1, Translucent 2, Translucent Modifier 5, Glaze (10g) 1, Incisio (3g) 1, liquids 25mL Glaze Liquid, 50mL Modeling Liquid
Catalog Number
877008
Brand Name
GC Initial™
Version/Model Number
877008
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 01, 2016
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
K040567
Product Code
EIH
Product Code Name
POWDER, PORCELAIN
Public Device Record Key
03bbebc6-d7a6-487e-b0a8-b16a199156c0
Public Version Date
July 24, 2018
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 |