BEAUTICEM TRY-IN PASTE IVORY-L C0012

GUDID E235C00120

BEAUTICEM TRY-IN PASTE IVORY-L

SHOFU DENTAL CORPORATION

Dental composite resin

• Primary Device ID: E235C00120
• NIH Device Record Key: 07045b96-24de-42a2-be38-d58b0b831855
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEAUTICEM TRY-IN PASTE IVORY-L
• Version Model Number: C0012
• Catalog Number: C0012
• 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: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E235C00120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180649

FDA Product Code

• KLE: AGENT, TOOTH BONDING, RESIN

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-11
• Device Publish Date: 2021-02-03

Devices Manufactured by SHOFU DENTAL CORPORATION

• 04548162310439 - BEAUTIFIL II: 2025-12-17 BEAUTIFIL II 4.5g A1 Syringe 1pc
• 04548162310446 - BEAUTIFIL II: 2025-12-17 BEAUTIFIL II 4.5g A2 Syringe 1pc
• 04548162310453 - BEAUTIFIL II: 2025-12-17 BEAUTIFIL II 4.5g A2O Syringe 1pc
• 04548162310460 - BEAUTIFIL II: 2025-12-17 BEAUTIFIL II 4.5g A3 Syringe 1pc
• 04548162310477 - BEAUTIFIL II: 2025-12-17 BEAUTIFIL II 4.5g A3.5 Syringe 1pc
• 04548162310484 - BEAUTIFIL II: 2025-12-17 BEAUTIFIL II 4.5g A3O Syringe 1pc
• 04548162310491 - BEAUTIFIL II: 2025-12-17 BEAUTIFIL II 4.5g A4 Syringe 1pc
• 04548162310507 - BEAUTIFIL II: 2025-12-17 BEAUTIFIL II 4.5g B1 Syringe 1pc