RESIN GLAZE Y0004

GUDID E235Y00040

RESIN GLAZE LIQUID

SHOFU DENTAL CORPORATION

Dental unfilled resin sealant/coating

• Primary Device ID: E235Y00040
• NIH Device Record Key: 496f2e23-31a9-4798-bb3e-ecf91b97e781
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESIN GLAZE
• Version Model Number: Y0004
• Catalog Number: Y0004
• 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(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com
• Phone: +1(800)827-5262
• Email: customer-service@shofu.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E235Y00040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050401

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: 2021-02-11
• Device Publish Date: 2021-02-03

Devices Manufactured by SHOFU DENTAL CORPORATION

• E2351000T0 - TRINIA: 2026-03-16 TRINIA DISC 98mm x 15mm Ivory
• E2351000TP0 - TRINIA: 2026-03-16 TRINIA DISC 98mm x 15mm Pink
• E2351001T0 - TRINIA: 2026-03-16 TRINIA DISC 98mm x 25mm Ivory
• E2351001TP0 - TRINIA: 2026-03-16 TRINIA DISC 98mm x 25mm Pink
• E2351002T0 - TRINIA: 2026-03-16 TRINIA BLOCK 55mm x 19mm x 15mm Ivory
• E2351003T0 - TRINIA: 2026-03-16 TRINIA BLOCK 40mm x 19mm x 15mm Ivory
• E2351004T0 - TRINIA: 2026-03-16 TRINIA D-SHAPE 89mm x 71mm x 15mm Ivory
• E2351004TP0 - TRINIA: 2026-03-16 TRINIA D-SHAPE 89mm x 71mm x 15mm Pink