PIC

GUDID 00348783000146

PREMIER IMPLANT CEMENT VALUE PACK

PREMIER DENTAL PRODUCTS COMPANY

Dental composite resin

• Primary Device ID: 00348783000146
• NIH Device Record Key: 96ff5872-64de-4127-bdf3-edd91c6884ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIC
• Version Model Number: 3001455
• 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	00348783000146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033309

FDA Product Code

• EMA: Cement, Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-12-15
• Device Publish Date: 2016-09-21

On-Brand Devices [PIC]

• 00348783000566: PIC Syringe 2.5mL Sample
• 00348783000146: PREMIER IMPLANT CEMENT VALUE PACK
• 00348783000139: PIC Standard Pack