CLEARBITE J00256

GUDID D813J002561

CLEARBITE CART SET RMO

DEN-MAT HOLDINGS, LLC

Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material 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

• D8130398114010 - TENURE: 2024-05-16 TENURE MPB SYSTEM BAG
• D8130398140000 - TENURE: 2024-05-16 TENURE 4G SAMPLE PACK
• D813444000L0 - CCD BLUEWAVE LASER: 2023-10-18 CCD LASER WIRELESS LOANER
• D8130561006970 - VAKT: 2023-04-26 VAKT ALIGNER UPR & LWR
• D8130303761050 - GBLOCK: 2023-03-14 GBLOCK DESENSITIZER 5ml
• D8130303761100 - GBLOCK: 2023-03-14 GBLOCK DESENSITIZER 10ml
• D8130562005300 - VAKT PRIVATE LABEL: 2023-03-14 VAKT ALIGNER UPPER
• D8130562005350 - ORTHOCLEAR - PL VAKT: 2023-03-14 VAKT ALIGNER LOWER