HY-Bond Polycarboxylate Temporary Cement 1173

GUDID E23511730

HY-BOND POLY TEMP CEM 125/60

SHOFU DENTAL CORPORATION

Zinc polycarboxylate dental cement

• Primary Device ID: E23511730
• NIH Device Record Key: 50b06284-5166-4f6f-a539-d522a9f09939
• Commercial Distribution Discontinuation: 2020-11-30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HY-Bond Polycarboxylate Temporary Cement
• Version Model Number: 1173
• Catalog Number: 1173
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23511730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002461

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: 4
• Public Version Date: 2019-10-16
• Device Publish Date: 2016-09-23

Devices Manufactured by SHOFU DENTAL CORPORATION

• 84548162303703 - BEAUTIFIL Needle Tips: 2025-12-23 BEAUTIFIL Needle Tips 18G 50pcs
• 84548162303710 - BEAUTIFIL Needle Tips: 2025-12-23 BEAUTIFIL Needle Tips 20G 50pcs
• 84548162303727 - BEAUTIFIL Needle Tips: 2025-12-23 BEAUTIFIL Needle Tips 20G-L 50pcs
• 84548162303734 - BeautiSealant Needle Tips: 2025-12-23 BeautiSealant Needle Tips 23G 50pcs
• 84548162303741 - BeautiSealant Needle Tips: 2025-12-23 BeautiSealant Needle Tips 27G 50pcs
• 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