PINK Preparation Bur 8205K1

GUDID E2358205K10

Contains DIs: E235094810; E235094910; E235085510; E235085610; E235840V10

SHOFU DENTAL CORPORATION

Dental abrasive point, reusable

• Primary Device ID: E2358205K10
• NIH Device Record Key: ae3144d3-cd20-403c-820d-ef6baffb9ac6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PINK Preparation Bur
• Version Model Number: 001
• Catalog Number: 8205K1
• Company DUNS: 054618202
• Company Name: SHOFU DENTAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E2358205K10 [Primary]

FDA Product Code

• EHL: POINT, ABRASIVE

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: 2022-09-29
• Device Publish Date: 2022-09-21

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