AccessGUDID - DEVICE: Jade (00353045000628)

GUDID

Device Identifier (DI) Information

Brand Name: Jade
Version or Model: 20-00005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-00005
Company Name: DHARMA RESEARCH, INC.

Primary DI Number: 00353045000628
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078444642 *Terms of Use

Device Description: Jade Blue 37% Phosphoric Acid Etchant Gel - 1 x 50ml Syringe, 50 Pre-bent 23ga Tips, 4 x 1.2ml Empty Syringes & Instruction Insert Instruction Insert

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36153	Dental tooth-etching solution	An acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLE	Agent, Tooth Bonding, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150696	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 50 Milliliter

Device Record Status

Public Device Record Key: 34aef14f-921e-4e8e-a797-d6969972b0f2
Public Version Date: October 09, 2025
Public Version Number: 4
DI Record Publish Date: October 07, 2016