Duns Number:005473608
Device Description: GC Fuji ORTHO™ LC Automix Starter set (1 x 13.3g (7.2mL) Cartridge, 1 x GC Paste Pak Dispe GC Fuji ORTHO™ LC Automix Starter set (1 x 13.3g (7.2mL) Cartridge, 1 x GC Paste Pak Dispenser, 20 x GC Mixing Tip for LC, 2 x 1.4g (1.2mL) GC ORTHO GEL CONDITIONER Syringe, 15 x Brush tips)
Catalog Number
439487
Brand Name
GC Fuji ORTHO™
Version/Model Number
439487
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 04, 2021
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
K073588
Product Code
DYH
Product Code Name
ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN
Public Device Record Key
6105dfb5-faad-4cec-8275-6c001671585d
Public Version Date
August 04, 2021
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 |