GC KommonBaseTM 90-1200-0000

GUDID E53590120000001

GC KommonBaseTM HV Clear 2 syringe pack

Gc Orthodontics America Inc.

Light-cured dental restorative composite resin

• Primary Device ID: E53590120000001
• NIH Device Record Key: 0354d764-a0ae-4aa1-b043-f666eb067a3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GC KommonBaseTM
• Version Model Number: 90-1200-0000
• Catalog Number: 90-1200-0000
• 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	E53590120000001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143667

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

On-Brand Devices [GC KommonBaseTM]

• E53590130000001: GC KommonBaseTM LV Pink 2 syringe pack
• E53590120000001: GC KommonBaseTM HV Clear 2 syringe pack