TRINIA 1001T

GUDID E2351001T0

TRINIA DISC 98mm x 25mm Ivory

SHOFU DENTAL CORPORATION

Dental implant suprastructure, permanent, preformed

• Primary Device ID: E2351001T0
• NIH Device Record Key: 007f4b6b-2a3f-40c3-b551-9a64971ab503
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRINIA
• Version Model Number: 1001T
• Catalog Number: 1001T
• 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: true
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E2351001T0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143524

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: 2026-03-16
• Device Publish Date: 2026-03-06

On-Brand Devices [TRINIA]

• E2351004TP0: TRINIA D-SHAPE 89mm x 71mm x 15mm Pink
• E2351004T0: TRINIA D-SHAPE 89mm x 71mm x 15mm Ivory
• E2351003T0: TRINIA BLOCK 40mm x 19mm x 15mm Ivory
• E2351002T0: TRINIA BLOCK 55mm x 19mm x 15mm Ivory
• E2351001TP0: TRINIA DISC 98mm x 25mm Pink
• E2351001T0: TRINIA DISC 98mm x 25mm Ivory
• E2351000TP0: TRINIA DISC 98mm x 15mm Pink
• E2351000T0: TRINIA DISC 98mm x 15mm Ivory