Duns Number:005473608
Device Description: GC Fuji ORTHO™ LC Introductory Package (1 x 15g powder, 1 x 6.8mL liquid, 1 x scoop & 1 x GC Fuji ORTHO™ LC Introductory Package (1 x 15g powder, 1 x 6.8mL liquid, 1 x scoop & 1 x mixing pad)
Catalog Number
439401
Brand Name
GC Fuji ORTHO™
Version/Model Number
439401
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
K981461,K981461
Product Code
DYH
Product Code Name
ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN
Public Device Record Key
1c565326-09fb-47c8-90fd-be00f545ff08
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 01, 2016
Package DI Number
D6584394012
Quantity per Package
5
Contains DI Package
D6584394011
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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 |