CLEARBITE J00256

GUDID D813J002561

CLEARBITE CART SET RMO

DEN-MAT HOLDINGS, LLC

Silicone dental impression material

• Primary Device ID: D813J002561
• NIH Device Record Key: 38bdc2fc-bcb5-4c08-84c2-45ca0621f8f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARBITE
• Version Model Number: J00256
• Catalog Number: J00256
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: 1-800-433-6628
• Email: infor@denmat.com
• Phone: 1-800-433-6628
• Email: infor@denmat.com
• Phone: 1-800-433-6628
• Email: infor@denmat.com
• Phone: 1-800-433-6628
• Email: infor@denmat.com
• Phone: 1-800-433-6628
• Email: infor@denmat.com
• Phone: 1-800-433-6628
• Email: infor@denmat.com
• Phone: 1-800-433-6628
• Email: infor@denmat.com
• Phone: 1-800-433-6628
• Email: infor@denmat.com
• Phone: 1-800-433-6628
• Email: infor@denmat.com
• Phone: 1-800-433-6628
• Email: infor@denmat.com
• Phone: 1-800-433-6628
• Email: infor@denmat.com
• Phone: 1-800-433-6628
• Email: infor@denmat.com
• Phone: 1-800-433-6628
• Email: infor@denmat.com
• Phone: 1-800-433-6628
• Email: infor@denmat.com
• Phone: 1-800-433-6628
• Email: infor@denmat.com
• Phone: 1-800-433-6628
• Email: infor@denmat.com
• Phone: 1-800-433-6628
• Email: infor@denmat.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D813J00256 [Unit of Use]
HIBCC	D813J002561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030776

FDA Product Code

• ELW: Material, Impression

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-06-05

Devices Manufactured by DEN-MAT HOLDINGS, LLC

• 03598833235166 - EVANESCE: 2025-01-07 EVANESCE INJECTABLE ENW SYR
• 03598833235265 - EVANESCE: 2025-01-07 EVANESCE EVANESCE INJECTABLE
• 03598833235272 - EVANESCE: 2025-01-07 EVANESCE INJECTABLE A2U SYR
• 03598833235289 - EVANESCE: 2025-01-07 EVANESCE INJECTABLE B1U SYR
• 03598833235296 - EVANESCE: 2025-01-07 EVANESCE INJECTABLE BL1U SYR
• 03598833235302 - EVANESCE: 2025-01-07 EVANESCE INJECTABLE A3U SYR
• 00359883973216 - EVANESCE: 2024-12-23 EVANESCE BULK CURE A2 SY 1x3g
• 03598833215236 - EVANESCE: 2024-12-23 EVANESCE BULK FILL A2 SY 1X6G