G-CEM One 013670

GUDID 04548161300394

G-CEM ONE Starter Kit A2 GCA

Gc America Inc.

Dental composite resin

• Primary Device ID: 04548161300394
• NIH Device Record Key: b5ebf444-7c22-45c3-8237-da831170685b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G-CEM One
• Version Model Number: 013670
• Catalog Number: 013670
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *away from heat, moisture and direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04548161300394 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200798

FDA Product Code

• EMA: CEMENT, DENTAL

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: 2022-11-15
• Device Publish Date: 2022-11-07

On-Brand Devices [G-CEM One]

• D0470136761: G-CEM ONE Single Refill White Opaque GCA
• D0470136751: G-CEM ONE Single Refill AO3 GCA
• D0470136741: G-CEM ONE Twin Refill Translucent GCA
• D0470136731: G-CEM ONE Twin Refill A2 GCA
• D0470136721: G-CEM ONE System Kit GCA
• D0470136711: G-CEM ONE Starter Kit Translucent GCA
• D0470136701: G-CEM ONE Starter Kit A2 GCA
• D0470136421: G-CEM ONE Adhesive Enhancing Primer GCA
• 04548161396250: G-CEM ONE Universal System Kit GCA
• 04548161322037: G-CEM ONE Adhesive Enhancing Primer GCA
• 04548161300455: G-CEM ONE Single Refill White Opaque GCA
• 04548161300448: G-CEM ONE Single Refill AO3 GCA
• 04548161300431: G-CEM ONE Twin Refill Translucent GCA
• 04548161300424: G-CEM ONE Twin Refill A2 GCA
• 04548161300417: G-CEM ONE System Kit GCA
• 04548161300400: G-CEM ONE Starter Kit Translucent GCA
• 04548161300394: G-CEM ONE Starter Kit A2 GCA