Prime Dent Light Cure One Step Dentin/Enamel Bonding Adhesive

GUDID 00817441022658

A 5th generation, single component, multi-use adhesive and glue.

PRIME DENTAL

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: 00817441022658
• NIH Device Record Key: 6c6afefc-d17c-4eca-b597-88f85a180bb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prime Dent Light Cure One Step Dentin/Enamel Bonding Adhesive
• Version Model Number: 006-030
• 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: true
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 773-283-2914
• Email: qa@primedentalmfg.com
• Phone: 773-283-2914
• Email: qa@primedentalmfg.com
• Phone: 773-283-2914
• Email: qa@primedentalmfg.com
• Phone: 773-283-2914
• Email: qa@primedentalmfg.com
• Phone: 773-283-2914
• Email: qa@primedentalmfg.com
• Phone: 773-283-2914
• Email: qa@primedentalmfg.com
• Phone: 773-283-2914
• Email: qa@primedentalmfg.com
• Phone: 773-283-2914
• Email: qa@primedentalmfg.com
• Phone: 773-283-2914
• Email: qa@primedentalmfg.com
• Phone: 773-283-2914
• Email: qa@primedentalmfg.com
• Phone: 773-283-2914
• Email: qa@primedentalmfg.com
• Phone: 773-283-2914
• Email: qa@primedentalmfg.com
• Phone: 773-283-2914
• Email: qa@primedentalmfg.com
• Phone: 773-283-2914
• Email: qa@primedentalmfg.com
• Phone: 773-283-2914
• Email: qa@primedentalmfg.com
• Phone: 773-283-2914
• Email: qa@primedentalmfg.com
• Phone: 773-283-2914
• Email: qa@primedentalmfg.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817441022658 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001108

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-29
• Device Publish Date: 2023-11-21

Devices Manufactured by PRIME DENTAL

• 00817441022658 - Prime Dent Light Cure One Step Dentin/Enamel Bonding Adhesive: 2023-11-29A 5th generation, single component, multi-use adhesive and glue.
• 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: 2018-07-06 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