DEVICE: Jade (00353045000680)
Device Identifier (DI) Information
Jade
20-00007
In Commercial Distribution
20-00007
DHARMA RESEARCH, INC.
20-00007
In Commercial Distribution
20-00007
DHARMA RESEARCH, INC.
Jade Green 37% Phosphoric Acid Etchant Gel - 1 x 10ml Syringe, 20 Pre-bent 23ga Tips & Instruction Insert
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Dental etching solution | An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused. |
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 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 10 Milliliter |
Device Record Status
0d882b0d-d1fc-4d63-a1ce-dcb433cf11d4
March 29, 2018
2
October 07, 2016
March 29, 2018
2
October 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 |
---|---|---|---|---|---|
10353045000687 | 48 | 00353045000680 | In Commercial Distribution | Case |
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
[?]
+3054829669
rcarles@dharmaresearch.com 8778333725
info@dharmaresearch.com
rcarles@dharmaresearch.com 8778333725
info@dharmaresearch.com