GC Ortho ConnectTM 90-1100-0000

GUDID E53590110000001

GC Ortho ConnectTM 2 syringe pack

Gc Orthodontics America Inc.

Orthodontic bracket adhesive

• Primary Device ID: E53590110000001
• NIH Device Record Key: d37a6d13-8aff-45aa-9d1a-491f82ae2ec6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GC Ortho ConnectTM
• Version Model Number: 90-1100-0000
• Catalog Number: 90-1100-0000
• Company DUNS: 063167128
• Company Name: Gc Orthodontics 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)897-8859
• Email: GCOAInfo@gcorthodontics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E53590110000001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150128

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-01

Devices Manufactured by Gc Orthodontics America Inc.

• D78811201CC511201 - EXPERIENCE: 2023-04-07 EXP C U/L 5-5 L 3-3 EXP M L 4,5 HK 345
• D78811202AA597521 - EXPERIENCE: 2023-04-07 EXPC CCO U5-5 EXPM MBT L5-5 022 hks345
• D78812202AA519151 - EXPERIENCE: 2023-04-07 EXCM U5-5 EXPM L5-5 MBT 022 HK345
• D788122C0500101 - EXPERIENCE: 2023-04-07 EXMC ROTH 022 U5-5 HK 345
• D788151CC5S0101 - CHIC: 2023-04-07 CHIC MINI ROTH 018 HK 3,4,5
• D788152CC5S0101 - CHIC: 2023-04-07 CHIC MINI ROTH 018 HK 3,4,5
• D788312BB5GP201 - LEGEND: 2023-04-07 LMI GOLD MBT 022 U/L 6-6 HK 345
• D788312CC542191 - LEGEND: 2023-04-07 LMI ROTH U 2-2 MBT 345 HK 345