Duns Number:005473608
Device Description: G-aenial™ Sculpt Unitip Intro Kit, 20 unitips of each of (Shade A1, A2, & A3 only; 0.16mL G-aenial™ Sculpt Unitip Intro Kit, 20 unitips of each of (Shade A1, A2, & A3 only; 0.16mL each) & 1 G-Premio Bond Kit (5mL)
Catalog Number
401100
Brand Name
G-aenial™
Version/Model Number
401100
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K123631,K123631
Product Code
EBF
Product Code Name
MATERIAL, TOOTH SHADE, RESIN
Public Device Record Key
908a0a84-c8b0-4345-ac99-896f61877050
Public Version Date
July 06, 2018
Public Version Number
3
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 |