Prime-Dent Visible Light Cure Nano-Hybrid Composite

GUDID 00817441020005

Visible Light Cure Nano-Hybrid Composite

PRIME DENTAL

Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set

• Primary Device ID: 00817441020005
• NIH Device Record Key: 97532162-6954-438b-b8f3-126509dfea51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prime-Dent Visible Light Cure Nano-Hybrid Composite
• Version Model Number: 001-610
• Company DUNS: 027480775
• Company Name: PRIME DENTAL
• 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: 773-283-2914
• Email: primedental@hotmail.com
• Phone: 773-283-2914
• Email: primedental@hotmail.com
• Phone: 773-283-2914
• Email: primedental@hotmail.com
• Phone: 773-283-2914
• Email: primedental@hotmail.com
• Phone: 773-283-2914
• Email: primedental@hotmail.com
• Phone: 773-283-2914
• Email: primedental@hotmail.com
• Phone: 773-283-2914
• Email: primedental@hotmail.com
• Phone: 773-283-2914
• Email: primedental@hotmail.com
• Phone: 773-283-2914
• Email: primedental@hotmail.com
• Phone: 773-283-2914
• Email: primedental@hotmail.com
• Phone: 773-283-2914
• Email: primedental@hotmail.com
• Phone: 773-283-2914
• Email: primedental@hotmail.com
• Phone: 773-283-2914
• Email: primedental@hotmail.com
• Phone: 773-283-2914
• Email: primedental@hotmail.com
• Phone: 773-283-2914
• Email: primedental@hotmail.com
• Phone: 773-283-2914
• Email: primedental@hotmail.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 38 Degrees Fahrenheit and 76 Degrees Fahrenheit
• Storage Environment Temperature: Between 38 Degrees Fahrenheit and 76 Degrees Fahrenheit
• Storage Environment Temperature: Between 38 Degrees Fahrenheit and 76 Degrees Fahrenheit
• Storage Environment Temperature: Between 38 Degrees Fahrenheit and 76 Degrees Fahrenheit
• Storage Environment Temperature: Between 38 Degrees Fahrenheit and 76 Degrees Fahrenheit
• Storage Environment Temperature: Between 38 Degrees Fahrenheit and 76 Degrees Fahrenheit
• Storage Environment Temperature: Between 38 Degrees Fahrenheit and 76 Degrees Fahrenheit
• Storage Environment Temperature: Between 38 Degrees Fahrenheit and 76 Degrees Fahrenheit
• Storage Environment Temperature: Between 38 Degrees Fahrenheit and 76 Degrees Fahrenheit
• Storage Environment Temperature: Between 38 Degrees Fahrenheit and 76 Degrees Fahrenheit
• Storage Environment Temperature: Between 38 Degrees Fahrenheit and 76 Degrees Fahrenheit
• Storage Environment Temperature: Between 38 Degrees Fahrenheit and 76 Degrees Fahrenheit
• Storage Environment Temperature: Between 38 Degrees Fahrenheit and 76 Degrees Fahrenheit
• Storage Environment Temperature: Between 38 Degrees Fahrenheit and 76 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817441020005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994224

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: 2016-08-10

Devices Manufactured by PRIME DENTAL

• 00817441022658 - Prime Dent Light Cure One Step Dentin/Enamel Bonding Adhesive: 2023-11-29 A 5th generation, single component, multi-use adhesive and glue.
• 00817441023136 - Prime Dent Etchant Liquid: 2023-11-29 Etchant gel and conditioner.
• 00817441023549 - Scott's Select RC Cream 2-9gm Syringe: 2020-05-06 Scott's Select RC Cream 2-9gm Syringe
• 00817441020012 - Prime Dent Visible Light Cure Nano Hybrid Composite Shade: 2019-11-14 Restorative Composite
• 00817441020029 - Prime Dent Visible Light Cure Nano Hybrid Composite: 2019-11-14 Restorative Composite
• 00817441022269 - Prime-Crown: 2019-11-14 temporary Crown material
• 00817441020005 - Prime-Dent Visible Light Cure Nano-Hybrid Composite: 2018-07-06Visible Light Cure Nano-Hybrid Composite
• 00817441020005 - Prime-Dent Visible Light Cure Nano-Hybrid Composite: 2018-07-06 Visible Light Cure Nano-Hybrid Composite
• 00817441023556 - Prime-Core Chemical Cure Core Build Up: 2018-07-06 Prime Core Chemical Cure Core Build Up Kit 15g/15g WHITE