FIT SA Y2543

GUDID E235Y25430

FIT SA F00A4 2.2g

SHOFU DENTAL CORPORATION

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: E235Y25430
• NIH Device Record Key: 686cd849-51aa-479f-9b57-b0bc5a2296cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIT SA
• Version Model Number: 001
• Catalog Number: Y2543
• 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: false
• 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
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E235Y25430 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182869

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: 2022-10-26
• Device Publish Date: 2022-10-18

On-Brand Devices [FIT SA]

• E235Y25640: FIT SA F10 B1 2.2g
• E235Y25630: FIT SA F10 A4 2.2g
• E235Y25620: FIT SA F10 A3 2.2g
• E235Y25610: FIT SA F10 A2 2.2g
• E235Y25600: FIT SA F10 A1 2.2g
• E235Y25540: FIT SA F03B1 2.2g
• E235Y25530: FIT SA F03A4 2.2g
• E235Y25520: FIT SA F03A3 2.2g
• E235Y25510: FIT SA F03A2 2.2g
• E235Y25500: FIT SA F03A1 2.2g
• E235Y25720: FIT SA F10 A2 1G
• E235Y25710: FIT SA F03 A2 1G
• E235Y25690: FIT SA F10 A1 1G
• E235Y25680: FIT SA F03 A1 1G
• E235Y25440: FIT SA F00B1 2.2g
• E235Y25430: FIT SA F00A4 2.2g
• E235Y25420: FIT SA F00A3 2.2g
• E235Y25410: FIT SA F00A2 2.2g
• E235Y25400: FIT SA F00A1 2.2g