Duns Number:005473608
Device Description: GC Fuji ORTHO™ Band (Paste Pak) Starter Package (2 x 13.3 g (7.2mL) cartridges, 1 x mixing GC Fuji ORTHO™ Band (Paste Pak) Starter Package (2 x 13.3 g (7.2mL) cartridges, 1 x mixing pad, 1 x GC Paste Pak Dispenser & 1 x GC Fuji SPATULA)
Catalog Number
439460
Brand Name
GC Fuji ORTHO™
Version/Model Number
439460
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
K080724
Product Code
DYH
Product Code Name
ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN
Public Device Record Key
bec512d5-a255-4fba-a89d-abc831378e53
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 |