Jade

Basic Information

• Brand Name: Jade
• Primary DI: 00353045000659
• Version / Model: 20-00004
• Catalog Number: 20-00004
• Company Name: DHARMA RESEARCH, INC.
• Labeler DUNS: 078444642
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-10-07
• Public Version: 4
• Public Version Date: 2025-10-09
• Public Version Status: Update
• Public Device Record Key: 9099f5cb-8a96-430b-b2c9-fb29374708cd

Device Description

Jade Blue 37% Phosphoric Acid Etchant Gel Kit - 25 x 1.2ml Syringes, 50 Pre-bent 23ga Tips & Instruction Insert

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KLE	Agent, Tooth Bonding, Resin	Dental	872.3200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10353045000656	GS1	Case	30	In Commercial Distribution
Primary	00353045000659	GS1
Unit of Use	00353045002622	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K150696	000

Device Sizes

Type	Value	Unit	Text
Total Volume	1.2	Milliliter