P&R Repair Kit 1739

GUDID E23517390

P&R REPAIR KIT

SHOFU DENTAL CORPORATION

Dental prosthesis restorative material, unfilled resin

• Primary Device ID: E23517390
• NIH Device Record Key: 0ba30bb9-8d86-4a9a-afc4-a592cf4c9e54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P&R Repair Kit
• Version Model Number: 1739
• Catalog Number: 1739
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23517390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123119

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

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: 2018-08-09
• Device Publish Date: 2016-09-24

Devices Manufactured by SHOFU DENTAL CORPORATION

• E235D18B1MN0 - DENTADISC: 2026-02-10 DentaDisc CAD/CAM PMMA Disc 98.5x18mm B1.MN
• E235D20A1MN0 - DENTADISC: 2026-02-10 DentaDisc CAD/CAM PMMA DISC. 98.5X20mm A1. MN
• E235D20B1MN0 - DENTADISC: 2026-02-10 DentaDisc CAD/CAM PMMA DISC 98.5x20mm B1.MN
• E235D25A1MN0 - DENTADISC: 2026-02-10 DentaDisc CAD/CAM PMMA DISC. 98.5X25mm A1. MN
• E235D25A2MN0 - DENTADISC: 2026-02-10 DentaDisc CAD/CAM PMMA DISC. 98.5x25mm A2. MN
• E235D30A1MN0 - DENTADISC: 2026-02-10 DentaDisc CAD/CAM PMMA DISC.98.5x30mm A1. MN
• E235D30A2MN0 - DENTADISC: 2026-02-10 DentaDisc CAD/CAM PMMA DISC. 98.5X30mm A2. MN
• E235D30B1MN0 - DENTADISC: 2026-02-10 DentaDisc CAD/CAM PMMA DISC. 98.5X30mm B1. MN