DEVICE: GC Fuji LINING™ (D0470000211)
Device Identifier (DI) Information
GC Fuji LINING™
000021
In Commercial Distribution
000021
Gc America Inc.
000021
In Commercial Distribution
000021
Gc America Inc.
GC Fuji LINING™ Intro Package, 1-1 Pack (1 x 10 g powder, 1 x 6.8 mL liquid & accessories)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
16182 | Dental cavity liner |
A substance intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth from chemical irritation. The device is typically a thin layer of zinc oxide (ZnO) and eugenol (C10H12O2), or calcium hydroxide (Ca(OH)2). After application, this device cannot be reused.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EJK | LINER, CAVITY, CALCIUM HYDROXIDE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K901999 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 4 and 25 Degrees Celsius |
Storage Environment Temperature: between 39 and 77 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
7d8fc475-e5b0-4f50-b0e6-b24700e2d3bd
July 06, 2018
3
August 01, 2016
July 06, 2018
3
August 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
D0470000212 | 5 | D0470000211 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(708)597-0900
customerservice@gcamerica.com
customerservice@gcamerica.com