EXABITE™ 132418

GUDID D6581324181

EXABITE™ II NDS Pack of 8 cartridges, 48mL each & 12 x mixing tips size L

Gc America Inc.

Polyether dental impression material

• Primary Device ID: D6581324181
• NIH Device Record Key: 9f88c387-d9da-426a-b341-381f913133db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXABITE™
• Version Model Number: 132418
• Catalog Number: 132418
• 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
• 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 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 and 23 Degrees Celsius
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 and 23 Degrees Celsius
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 and 23 Degrees Celsius
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 and 23 Degrees Celsius
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 and 23 Degrees Celsius
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 and 23 Degrees Celsius
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 and 23 Degrees Celsius
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 and 23 Degrees Celsius
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 and 23 Degrees Celsius
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 and 23 Degrees Celsius
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 and 23 Degrees Celsius
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 and 23 Degrees Celsius
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 0 and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D6581324181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933206

FDA Product Code

• ELW: MATERIAL, IMPRESSION

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2026-01-21
• Device Publish Date: 2016-08-01

On-Brand Devices [EXABITE™]

• 10386040004978: EXABITE™ II NDS Pack of 8 cartridges, 48mL each & 12 x mixing tips size L
• 10386040004961: EXABITE™ II NDS Pack of 2 cartridges, 48mL each & 12 x mixing tips size L
• D6581324181: EXABITE™ II NDS Pack of 8 cartridges, 48mL each & 12 x mixing tips size L
• D6581324121: EXABITE™ II NDS Pack of 2 cartridges, 48mL each & 12 x mixing tips size L