HY-Bond Resiglass 3280

GUDID E23532800

Hy-Bond Resiglass Capsules (50Pcs)

SHOFU DENTAL CORPORATION

Dental composite resin

• Primary Device ID: E23532800
• NIH Device Record Key: 5a579480-7154-4c11-9fd9-20033479522b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HY-Bond Resiglass
• Version Model Number: 3280
• Catalog Number: 3280
• Company DUNS: 054618202
• Company Name: SHOFU DENTAL CORPORATION
• Device Count: 50
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23532800 [Primary]
HIBCC	E235328001 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111855

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: 2016-09-24

Devices Manufactured by SHOFU DENTAL CORPORATION

• E235D18A1ML0 - DENTADISC: 2026-02-02 DentaDisc CAD/CAM DISC. 98.5X18mm A1. ML
• E235D18A1MN0 - DENTADISC: 2026-02-02 DentaDisc CAD/CAM DISC. 98.5X18mm A1. MN
• E235D18A2ML0 - DENTADISC: 2026-02-02 PORTUX CAD/CAM DISC. 98.5X18mm A2. ML
• E235D18A2MN0 - DENTADISC: 2026-02-02 DentaDisc CAD/CAM DISC. 98.5X18mm A2. MN
• E235D18A35MN0 - DENTADISC: 2026-02-02 PORTUX CAD/CAM DISC. 98.5 x18mm A3.5. MN
• E235D18A3ML0 - DENTADISC: 2026-02-02 PORTUX CAD/CAM DISC. 98.5X18mm A3. ML
• E235D18A3MN0 - DENTADISC: 2026-02-02 DentaDisc CAD/CAM DISC. 98.5 x18mm A3. MN
• E235D18B1ML0 - DENTADISC: 2026-02-02 PORTUX CAD/CAM DISC. 98.5X18mm B1. ML