Duns Number:005473608
Device Description: GC Initial™ LF Entrance Kit Contains: Powder Opaque (OA3); Opaqus Dentin (ODA3); Enamel (E GC Initial™ LF Entrance Kit Contains: Powder Opaque (OA3); Opaqus Dentin (ODA3); Enamel (E-58 and E-59); INside (IN-44); Clear Fluorescence (CL-F); Enamel Opal (EOP2); Glaze Powder (10 g); Glaze Liquid (25 mL); Modeling Liquid (50 mL); Opaque Liquid (50 mL).
Catalog Number
877036
Brand Name
GC Initial™
Version/Model Number
877036
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
K040567
Product Code
EIH
Product Code Name
POWDER, PORCELAIN
Public Device Record Key
17742bbe-d9d4-4259-bbe5-f5b976b0a4b5
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 |