Duns Number:005473608
Device Description: GC Fuji TEMP LT™ Introductory Kit (2 x Paste Pak Cartridge 13.3g (7.2mL), 1 x mixing pad & GC Fuji TEMP LT™ Introductory Kit (2 x Paste Pak Cartridge 13.3g (7.2mL), 1 x mixing pad & 1 x GC Paste Pak Dispenser)
Catalog Number
437855
Brand Name
GC Fuji TEMP LT™
Version/Model Number
437855
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K101420
Product Code
EMA
Product Code Name
CEMENT, DENTAL
Public Device Record Key
701e4c0a-52a7-452c-b0f8-570ef3e909d3
Public Version Date
July 21, 2022
Public Version Number
1
DI Record Publish Date
July 13, 2022
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 |