DEVICE: Prime&Bond® NT™ Nano-Technology Light Cured Dental Adhesive (D0026343501)
Device Identifier (DI) Information
Prime&Bond® NT™ Nano-Technology Light Cured Dental Adhesive
634350
In Commercial Distribution
634350
DENTSPLY INTERNATIONAL INC.
634350
In Commercial Distribution
634350
DENTSPLY INTERNATIONAL INC.
Prime&Bond® NT™ Nano-Technology Dental Adhesive Introductory Kit
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
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 [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 10 and 24 Degrees Celsius |
Special Storage Condition, Specify: Keep away from sunlight. Keep dry. |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 1 Bottle P&B Adhesive (4.5mL), 40 Disposable Brush Tips, 1 Brush Handle, 1 Dispensing Well |
Total Volume: 4.5 Milliliter |
Device Record Status
c2957086-99c2-42e0-a284-f78a710a6f89
March 29, 2018
2
September 21, 2016
March 29, 2018
2
September 21, 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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)532-2855
MilfordDE-Customer-Service@dentsplysirona.com
MilfordDE-Customer-Service@dentsplysirona.com