Bosworth Light Liner 0921463

GUDID H66809214631

Hard P&L Standard Kit

Harry J Bosworth Company

Denture reliner, hard

• Primary Device ID: H66809214631
• NIH Device Record Key: 39f2c88c-2f5f-42d6-b26d-7657102b6eb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bosworth Light Liner
• Version Model Number: 0921463
• Catalog Number: 0921463
• 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 32 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H66809214631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981861

FDA Product Code

• EBI: RESIN, DENTURE, RELINING, REPAIRING, REBASING

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: 2018-08-09
• Device Publish Date: 2016-09-15

On-Brand Devices [Bosworth Light Liner]

• H6680921499S1: Soft Reline Mat. P&L Single Dose
• H66809214991: Hard Reline Mat. P&L Single Dose
• H66809214641: Soft Reline P&L Standard Kit
• H66809214631: Hard P&L Standard Kit