CLASS V PROCEDURE KIT CVPK

GUDID E235CVPK0

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

SHOFU DENTAL CORPORATION

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• 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

• E235P08111 - VINTAGE PRIME PRESS: 2024-04-12 VINTAGE PRIME PRESS 3g E-1 5pcs
• E235P08121 - VINTAGE PRIME PRESS: 2024-04-12 VINTAGE PRIME PRESS 3g E-2 5pcs
• E235P08131 - VINTAGE PRIME PRESS: 2024-04-12 VINTAGE PRIME PRESS 3g E-A1 5pcs
• E235P08141 - VINTAGE PRIME PRESS: 2024-04-12 VINTAGE PRIME PRESS 3g E-A2 5pcs
• E235P08151 - VINTAGE PRIME PRESS: 2024-04-12 VINTAGE PRIME PRESS 3g E-BL3 5pcs
• E235P08161 - VINTAGE PRIME PRESS: 2024-04-12 VINTAGE PRIME PRESS 3g E-BL4 5pcs
• E235P08201 - VINTAGE PRIME PRESS: 2024-04-12 VINTAGE PRIME PRESS 3g HT-A1 5pcs
• E235P08211 - VINTAGE PRIME PRESS: 2024-04-12 VINTAGE PRIME PRESS 3g HT-A2 5pcs