Acrylic Polishing Kit 0321

GUDID E23503210

Contains DIs: E23506160; E23506200; E23504230; E23504260; E23504270; E23504240; E23504280

SHOFU DENTAL CORPORATION

Dental abrasive point, reusable

• Primary Device ID: E23503210
• NIH Device Record Key: 225a3bf6-3231-4a8c-8e2a-08e1c69e376a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acrylic Polishing Kit
• Version Model Number: 001
• Catalog Number: 0321
• 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	E23503210 [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

• 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