G-CEM™ 439003

GUDID 00386040009419

G-CEM™ Starter Package (1 x 50 capsule assorted package, 1 x Capsule Applier)

Gc America Inc.

Silicone dental impression material

• Primary Device ID: 00386040009419
• NIH Device Record Key: 2bdda892-e081-4db7-982c-4fe1fd379254
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G-CEM™
• Version Model Number: 439003
• Catalog Number: 439003
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 50
• 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: true
• 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

Operating and Storage Conditions

• 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
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386040009419 [Unit of Use]
GS1	10386040009416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061535

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: 2022-07-21
• Device Publish Date: 2022-07-13

On-Brand Devices [G-CEM™]

• 00386040009419: G-CEM™ Starter Package (1 x 50 capsule assorted package, 1 x Capsule Applier)
• 04548161293504: G-CEM™ BO1, box of 50 capsules
• 04548161293498: G-CEM™ AO3, box of 50 capsules
• 04548161291135: G-CEM™ Capsule Elongation Tip (50 pcs)
• 04548161282409: G-CEM™ Translucent, box of 50 capsules
• 04548161282331: G-CEM™ Assorted, box of 50 capsules
• 04548161282256: G-CEM™ A2, box of 50 capsules