FIT SA Y2564

GUDID E235Y25640

FIT SA F10 B1 2.2g

SHOFU DENTAL CORPORATION

Dental composite resin

• Primary Device ID: E235Y25640
• NIH Device Record Key: c5247375-e01a-478f-a41c-1b93130a61e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIT SA
• Version Model Number: 001
• Catalog Number: Y2564
• 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: mmalzyner@shofu.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E235Y25640 [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: 2019-12-09
• Device Publish Date: 2019-12-01

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