DIAETCH A2001-3103

GUDID 08806383565172

Blue colored gel-type substance containing 37% phosphoric acid that corrodes enamel and dentine.

DiaDent Group International

Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution

• Primary Device ID: 08806383565172
• NIH Device Record Key: 1f60acdd-40d3-48aa-9d9c-cd38ecf7b57c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIAETCH
• Version Model Number: Regular Package
• Catalog Number: A2001-3103
• Company DUNS: 687789453
• Company Name: DiaDent Group International
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid expesure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid expesure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid expesure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid expesure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid expesure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid expesure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid expesure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid expesure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid expesure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid expesure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid expesure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid expesure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid expesure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid expesure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid expesure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid expesure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid expesure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid expesure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806383565172 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192273

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-04
• Device Publish Date: 2020-02-25

On-Brand Devices [DIAETCH]

• 08806383565196: Blue colored gel-type substance containing 37% phosphoric acid that corrodes enamel and dentine.
• 08806383565172: Blue colored gel-type substance containing 37% phosphoric acid that corrodes enamel and dentine.
• 08806383565158: Blue colored gel-type substance containing 37% phosphoric acid that corrodes enamel and dentine.