CompCORE AF

GUDID 00348783000733

COMPCORE AF DUAL CURE WHITE REFILL

PREMIER DENTAL PRODUCTS COMPANY

Dental composite resin

• Primary Device ID: 00348783000733
• NIH Device Record Key: 5623075a-7905-4ea5-9aea-8b5bb20ca221
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CompCORE AF
• Version Model Number: 3001432
• 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	00348783000733 [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: 2016-09-19

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