BioCoat

GUDID 00348783000870

BioCoat Pit/Fissure Bulk 5Pk (20)

PREMIER DENTAL PRODUCTS COMPANY

Dental composite resin

• Primary Device ID: 00348783000870
• NIH Device Record Key: 9212e5c2-e16b-412c-867d-0d45d8d12126
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioCoat
• Version Model Number: 3001532
• 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	00348783000870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161580

FDA Product Code

• EBC: Sealant, Pit And Fissure, And Conditioner

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: 2023-10-23
• Device Publish Date: 2023-10-13

On-Brand Devices [BioCoat]

• 00348783000887: Biocoat Sample
• 00348783000870: BioCoat Pit/Fissure Bulk 5Pk (20)
• 00348783000863: BioCoat Pit/Fissure Value Pk (4)
• 00348783000856: BioCoat Pit/Fissure Standard Pk (1)