Jade 20-00003

GUDID 10353045000649

Jade Blue 37% Phosphoric Acid Etchant Gel Kit - 4 x 1.2ml Syringes, 20 Pre-bent 23ga Tips & Instruction Insert

DHARMA RESEARCH, INC.

Dental etching solution

• Primary Device ID: 10353045000649
• NIH Device Record Key: c327023b-f468-49ea-b399-340a153ac404
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jade
• Version Model Number: 20-00003
• Catalog Number: 20-00003
• Company DUNS: 078444642
• Company Name: DHARMA RESEARCH, INC.
• Device Count: 4
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +3054829669
• Email: rcarles@dharmaresearch.com

Device Dimensions

• Total Volume: 1.2 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353045000642 [Primary]
GS1	00353045002622 [Unit of Use]
GS1	10353045000649 [Package]; Contains: 00353045000642; Package: Case [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150696

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-03-11
• Device Publish Date: 2016-10-07

On-Brand Devices [Jade]

• 10353045002131: Jade Green 37% Phosphoric Acid Etchant Gel - 1 x 50ml Syringe & Instruction Insert
• 10353045002124: Jade Blue 37% Phosphoric Acid Etchant Gel - 1 x 50ml Syringe & Instruction Insert
• 00353045000710: Jade Green 37% Phosphoric Acid Etchant Gel - 1 x 50ml Syringe, 50 Pre-bent 23ga Tips, 4 x 1.2ml
• 10353045000700: Jade Green 37% Phosphoric Acid Etchant Gel - 25 x 1.2ml Syringes, 50 Pre-bent 23ga Tips & Instru
• 10353045000694: Jade Green 37% Phosphoric Acid Etchant Gel - 4 x 1.2ml Syringes, 20 Pre-bent 23ga Tips & Instruc
• 10353045000687: Jade Green 37% Phosphoric Acid Etchant Gel - 1 x 10ml Syringe, 20 Pre-bent 23ga Tips & Instructi
• 10353045000670: Jade Green 37% Phosphoric Acid Etchant Gel - 1 x 10ml Syringe, 5 Pre-bent 23ga Tips & Instructio
• 10353045000663: Jade Blue 37% Phosphoric Acid Etchant Gel - 1 x 10ml Syringe, 5 Pre-bent 23ga Tips & 1 Instructi
• 10353045000656: Jade Blue 37% Phosphoric Acid Etchant Gel Kit - 25 x 1.2ml Syringes, 50 Pre-bent 23ga Tips & Ins
• 10353045000649: Jade Blue 37% Phosphoric Acid Etchant Gel Kit - 4 x 1.2ml Syringes, 20 Pre-bent 23ga Tips & Inst
• 10353045000632: Jade Blue 37% Phosphoric Acid Etchant Gel - 1 x 10ml Syringe, 20 Pre-bent 23ga Tips & Instructio
• 10353045000625: Jade Blue 37% Phosphoric Acid Etchant Gel - 1 x 50ml Syringe, 50 Pre-bent 23ga Tips, 4 x 1.2ml E