CompCORE AF

GUDID 00348783000771

CompCore AF SYRINGE MIX STACK- A3

PREMIER DENTAL PRODUCTS COMPANY

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 Dental composite resin

• Primary Device ID: 00348783000771
• NIH Device Record Key: 7ae20f28-6c57-4425-a61a-bff999e4c163
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CompCORE AF
• Version Model Number: 3001513
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00348783000771 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012160

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: 2023-10-16
• Device Publish Date: 2016-09-16

On-Brand Devices [CompCORE AF]

• 00348783000801: CompCore AF Syringe Mix Stack - A3 (9 gr) Blister
• 00348783000795: CompCore AF Syringe Mix Stack -White (9 gr) Blister
• 00348783000788: CompCore AF SYRINGE MIX STACK-BLUE
• 00348783000771: CompCore AF SYRINGE MIX STACK- A3
• 00348783000764: CompCore AF SYRINGE MIX STACK-WHITE
• 00348783000740: COMPCORE AF DUAL CURE A3 REFILL
• 00348783000733: COMPCORE AF DUAL CURE WHITE REFILL
• 00348783000726: COMPCORE AF DUAL CURE A3 INTRO KIT
• 00348783000719: COMPCORE AF DUAL CURE WHITE INTRO KIT