Cerinate® 030402550

GUDID D8130304025501

ETCH'N'SEAL RED 8pc SY KIT

DEN-MAT HOLDINGS, LLC

Dental etching solution

• Primary Device ID: D8130304025501
• NIH Device Record Key: 34c9d505-d58a-430b-af12-a9cb825ad456
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cerinate®
• Version Model Number: 030402550
• Catalog Number: 030402550
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• Device Count: 8
• DM Exempt: false
• Pre-market Exempt: true
• 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 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cold storage is not required
• 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 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8130304025500 [Unit of Use]
HIBCC	D8130304025501 [Primary]

FDA Product Code

• DYH: Adhesive, Bracket And Tooth Conditioner, 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: 2
• Public Version Date: 2018-03-29
• 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