Bosworth Dentusil 0921276

GUDID H66809212761

Dentusil Soft Reline Material, Standard Kit

Harry J Bosworth Company

Denture reliner, soft, professional

• Primary Device ID: H66809212761
• NIH Device Record Key: 64122754-8bbf-4644-8072-7ee74b472aa2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bosworth Dentusil
• Version Model Number: 0921276
• Catalog Number: 0921276
• 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	H66809212761 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981691

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [Bosworth Dentusil]

• H66809212781: Dentusil Soft Reline Adhesive
• H66809212761: Dentusil Soft Reline Material, Standard Kit
• H66809212751: Silicone Soft Reline Material Refill Cartridge