DEVICE: Tokuyama Bond Force (04548190149421)
Device Identifier (DI) Information
Tokuyama Bond Force
14942
In Commercial Distribution
TOKUYAMA DENTAL CORPORATION
14942
In Commercial Distribution
TOKUYAMA DENTAL CORPORATION
Pen, Twin Pen
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? |
---|---|---|---|---|
42483 | Dentine adhesive |
A material primarily used as a bonding-promoting substance between dentine and a composite filling, restorative or luting material. It may also be used as a bonding substance to enamel. After application, this device cannot be reused.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KLE | Agent, Tooth Bonding, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K070215 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 0 and 10 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
eec8563d-1fc5-44f7-b56b-c62416ca4172
July 06, 2018
3
September 23, 2016
July 06, 2018
3
September 23, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
94548190149370
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-877-378-3548
info@tokuyama-us.com
info@tokuyama-us.com