Cerinate® 030967101B

GUDID D813030967101B0

TETRAPQ D/C INIT 4g

DEN-MAT HOLDINGS, LLC

Dental composite resin

• Primary Device ID: D813030967101B0
• NIH Device Record Key: 3e7f8cfe-b454-434d-ba11-3c735b071a17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cerinate®
• Version Model Number: 030967101B
• Catalog Number: 030967101B
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• 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: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D813030967101B0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K841111

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Cerinate®]

• D813LUM10050: LUMINEERS STARTER KIT
• D8130339099500: CERI SH MOD II SYS CUSTOM KIT
• D8130339099000: SH MOD II SYSTEM BY CERINATE
• D8130313811000: LUMINEERS PLACEMENT KIT
• D813030967101B0: TETRAPQ D/C INIT 4g
• D8130304025501: ETCH'N'SEAL RED 8pc SY KIT