BeautiBond 1782

GUDID E23517820

BEAUTIBOND (50 Unit Kit)

SHOFU DENTAL CORPORATION

Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set

• Primary Device ID: E23517820
• NIH Device Record Key: 774671ad-e300-4b3b-89ae-c21e37a5bd44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BeautiBond
• Version Model Number: 1782
• Catalog Number: 1782
• Company DUNS: 054618202
• Company Name: SHOFU DENTAL CORPORATION
• 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: 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: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com
• Phone: 760-566-3528
• Email: ckaemmerlen@shofu.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23517820 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082744

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

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: 2016-09-26

On-Brand Devices [BeautiBond]

• E2351782100: 10 each Light-Cure Self-Etching One Component Dental Adhesive with 10 Microbrushes - Sample Pack
• E2351782250: 25 each Light-Cure Self-Etching One Component Dental Adhesive with 25 Microbrushes - Sample Pack
• E2351782S0: 2 each Light-Cure Self-Etching One Component Dental Adhesive with 2 Microbrushes - Sample Pack.
• E23517820500: 50 each Light-Cure Self-Etching One Component Dental Adhesive with 50 Microbrushes. Contains DI'
• E23517820: BEAUTIBOND (50 Unit Kit)
• E23517810: BEAUTIBOND BOTTLE (6ml)