BEAUTICEM TRY-IN PASTE IVORY-D C0013

GUDID E235C00130

BEAUTICEM TRY-IN PASTE IVORY-D

SHOFU DENTAL CORPORATION

Dental composite resin

• Primary Device ID: E235C00130
• NIH Device Record Key: 0261f170-e060-4136-8c53-e0ad364657c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEAUTICEM TRY-IN PASTE IVORY-D
• Version Model Number: C0013
• Catalog Number: C0013
• 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	E235C00130 [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

• E235IEWK0 - INCISAL EDGE WEAR KIT: 2024-10-24 IEWK (INCISAL EDGE WEAR KIT) Contains: Beautibond Bulk (E23517820), One Gloss PS IC (Bulk) In Pouch (E23501780). One Gloss PS
• 14548162335460 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D006EF 5pcs
• 14548162335477 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D007EF 5pcs
• 14548162335484 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D010EF 5pcs
• 14548162335491 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D027EF 5pcs
• 14548162335507 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D053EF 5pcs
• 14548162335514 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D054EF 5pcs
• 14548162335521 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D055EF 5pcs