DEVICE: Cavex Bite&White syringe (E241BW0100)
Device Identifier (DI) Information
Cavex Bite&White syringe
BW010
In Commercial Distribution
BW010
Cavex Holland B.V.
BW010
In Commercial Distribution
BW010
Cavex Holland B.V.
Dental Whitening Agent
Device Characteristics
MR Safe | |
No | |
No | |
No | |
No | |
Yes | |
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
38785 | Dental bleaching agent |
A dental liquid solution or a paste used to whiten teeth for therapeutic or cosmetic purposes. After application, this device cannot be reused.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EEG | Heat Source For Bleaching Teeth |
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 0 and 10 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 1 pcs |
Device Record Status
9138466e-4fbc-44c2-abcf-d2b2577a2395
March 29, 2018
2
July 07, 2016
March 29, 2018
2
July 07, 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
[?]
+31(0)235307700
r.woortman@cavex.nl
r.woortman@cavex.nl