Bosworth Hydrox 0921071

GUDID H66809210711

Cavity Liner Base & Catalyst Dentin Kit

Harry J Bosworth Company

Dental pulp-capping material

• Primary Device ID: H66809210711
• NIH Device Record Key: 790cdf7d-a5ef-4fb7-9cae-fb3e26892cfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bosworth Hydrox
• Version Model Number: 0921071
• Catalog Number: 0921071
• 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 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H66809210711 [Primary]

FDA Product Code

• EJK: LINER, CAVITY, CALCIUM HYDROXIDE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-15

On-Brand Devices [Bosworth Hydrox]

• H66809210741: Cavity Liner 6 pk Base & Catalyst Dentin Kit
• H66809210731: Cavity Liner 6 pk Base & Catalyst Ivory Kit
• H66809210721: Cavity Liner Base & Catalyst Ivory Kit
• H66809210711: Cavity Liner Base & Catalyst Dentin Kit