Zinc Phosphate Cement 1170

GUDID E23511700

HY-BOND ZINC KIT

SHOFU DENTAL CORPORATION

Zinc phosphate dental cement

• Primary Device ID: E23511700
• NIH Device Record Key: f696aa2b-2557-442f-96dd-9b1b7c91280c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zinc Phosphate Cement
• Version Model Number: 1170
• Catalog Number: 1170
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23511700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K810765

FDA Product Code

• EMA: Cement, Dental

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: 2016-09-26

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