Bosworth Copaliner 0921525

GUDID H66809215251

Cavity Varnish & Sealant Kit

Harry J Bosworth Company

Dental cavity varnish

• Primary Device ID: H66809215251
• NIH Device Record Key: 12eeb4f6-c8e5-4455-a493-4fef25d6f631
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bosworth Copaliner
• Version Model Number: 0921525
• Catalog Number: 0921525
• Company DUNS: 014769301
• Company Name: Harry J Bosworth 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H66809215251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933505

FDA Product Code

• LBH: VARNISH, CAVITY

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: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [Bosworth Copaliner]

• H66809215271: Copaliner Solvent
• H66809215261: Cavity Varnish
• H66809215251: Cavity Varnish & Sealant Kit