BioCoat

GUDID 00348783000870

BioCoat Pit/Fissure Bulk 5Pk (20)

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

• 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)