DEVICE: Jade (00353045000635)

Device Identifier (DI) Information

Jade
20-00002
In Commercial Distribution
20-00002
DHARMA RESEARCH, INC.
00353045000635
GS1

1
078444642 *Terms of Use
Jade Blue 37% Phosphoric Acid Etchant Gel - 1 x 10ml Syringe, 20 Pre-bent 23ga Tips & Instruction Insert
CLOSE

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KLE Agent, Tooth Bonding, Resin
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 25 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Total Volume: 10 Milliliter
CLOSE

Device Record Status

4dcc8c97-1e1a-49cf-8d61-0be593b74ea3
March 29, 2018
2
October 07, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10353045000632 48 00353045000635 In Commercial Distribution Case
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+3054829669
rcarles@dharmaresearch.com
8778333725
info@dharmaresearch.com
CLOSE