One Gloss PS Sample Pack OGPS/SAMPLE

GUDID E235OGPSSAMPLE0

Contains DIs: E23501770; E23501760; E23501780

SHOFU DENTAL CORPORATION

Dental polishing cup, single-use

• Primary Device ID: E235OGPSSAMPLE0
• NIH Device Record Key: 87cef698-c9e5-4ed7-94c7-a95b466893f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: One Gloss PS Sample Pack
• Version Model Number: 001
• Catalog Number: OGPS/SAMPLE
• 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
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E235OGPSSAMPLE0 [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: 2022-09-30
• Device Publish Date: 2022-09-22

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