GC ORTHO GEL CONDITIONER 003104

GUDID 14548161293945

GC ORTHO GEL CONDITIONER (3 x 1.4 g (1.2 mL) Syringe 25 x Brush tip

Gc America Inc.

Dental etching solution

• Primary Device ID: 14548161293945
• NIH Device Record Key: 97c46f3f-71c7-4ca1-a315-3d9facb6ad2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GC ORTHO GEL CONDITIONER
• Version Model Number: 003104
• Catalog Number: 003104
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 1
• DM Exempt: false
• 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

Customer Support Contacts

• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com

Device Dimensions

• Weight: 13.3 Gram
• Weight: 13.3 Gram
• Weight: 13.3 Gram
• Weight: 13.3 Gram
• Weight: 13.3 Gram
• Weight: 13.3 Gram
• Weight: 13.3 Gram
• Weight: 13.3 Gram
• Weight: 13.3 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	14548161293945 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073588

FDA Product Code

• DYH: ADHESIVE, BRACKET AND TOOTH CONDITIONER, 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: 2022-08-15
• Device Publish Date: 2022-08-05

Devices Manufactured by Gc America Inc.

• 14550565002269 - Cytrans Granules: 2026-03-11 Cytrans Granules L 0.5g 1pc
• 14550565002276 - Cytrans Granules: 2026-03-11 Cytrans Granules L 2.0g 1pc
• D047014615 - Cytrans Granules: 2026-03-11 Cytrans Granules L 0.5g 1pc
• D047014616 - Cytrans Granules: 2026-03-11 Cytrans Granules L 2.0g 1pc
• D6581200012 - COE ALGINATE™: 2026-01-21 COE ALGINATE™ Normal set, mint, 1 x 1lb powder and 1 x scoop
• D6581200051 - COE ALGINATE™: 2026-01-21 COE ALGINATE™ Normal set, mint, 1 x 5lb powder and 1 x scoop
• D6581200251 - COE ALGINATE™: 2026-01-21 COE ALGINATE™ Normal set, mint, 5 x 5lb powder (25lb total)
• D6581201012 - COE ALGINATE™: 2026-01-21 COE ALGINATE™ Fast set, mint, 1 x 1lb powder and 1 x scoop