CLASS V PROCEDURE KIT CVPK

GUDID E235CVPK0

CLASS V PROCEDURE KIT. Contains DI's: E23505020, E23505030, E235Y24510, E2351782S0

SHOFU DENTAL CORPORATION

Dental composite resin

• Primary Device ID: E235CVPK0
• NIH Device Record Key: 8c642810-7822-4e0f-985c-f755b596074b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLASS V PROCEDURE KIT
• Version Model Number: CVPK
• Catalog Number: CVPK
• 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: true
• 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
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage 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	E235CVPK0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172530

FDA Product Code

• EBF: MATERIAL, TOOTH SHADE, 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: 2021-02-26
• Device Publish Date: 2021-02-18

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