SHINING 3D®

GUDID 06975338700370

Hangzhou SHINING3D Dental Technology Co., Ltd.

Custom-made dental crown, polymer

• Primary Device ID: 06975338700370
• NIH Device Record Key: 56f88fa0-1e60-4968-a9c8-5f8ebf1162a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHINING 3D®
• Version Model Number: CB21-A1
• Company DUNS: 406871432
• Company Name: Hangzhou SHINING3D Dental Technology Co., Ltd.
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975338700370 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253053

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: 2025-12-17
• Device Publish Date: 2025-12-09

On-Brand Devices [SHINING 3D®]

• 06975338700264: The product is used for 3D printing denture teeth.
• 06975338700257: The product is used for 3D printing denture teeth.
• 06975338700240: The product is used for 3D printing denture teeth.
• 06975338700233: The product is used for 3D printing denture teeth.
• 06975338700226: The product is used for 3D printing denture teeth.
• 06975338700219: The product is used for 3D printing denture teeth.
• 06975338700134: The product is used for 3D printing denture teeth.
• 06975338700110: The product is used for 3D Printing dental try-in model.
• 06975338700097: The product is used for 3D Printing dental try-in model.
• 06975338700028: The product is used for 3D Printing dental try-in model.
• 06975338700295: The product is used for 3D Printing dental try-in model.
• 06975338700288: The product is used for 3D Printing dental try-in model.
• 06975338700189: The product is used for 3D Printing dental try-in model.
• 06975338700158: The product is used for the fabrication of preformed tooth positioner by dental professionals.
• 06975338700202: The product is used for the fabrication of preformed tooth positioner by dental professionals.
• 06975338700592: The product is used for 3D Printing dental try-in model.
• 06975338700585: The product is used for 3D Printing dental try-in model.
• 06975338700578: The product is used for 3D Printing dental try-in model.
• 06975338700561: The product is used for 3D Printing dental try-in model.
• 06975338700554: The product is used for 3D Printing dental try-in model.
• 06975338700547: The product is used for 3D Printing dental try-in model.
• 06975338700127: The product is used for 3D Printing dental try-in model.
• 06975338700172: The product is used for 3D Printing indirect bonding tray.
• 06975338700141: The product is used for 3D Printing dental surgical guide.
• 06975338701674: The product is used for 3D Printing dental model.
• 06975338700455: Denture Base Resin is a light-curable polymerizable resin intended to be used for the fabricatio
• 06975338700448: Denture Base Resin is a light-curable polymerizable resin intended to be used for the fabricatio
• 06975338700431: Denture Base Resin is a light-curable polymerizable resin intended to be used for the fabricatio
• 06975338701308: The product is used for 3D Printing dental try-in model.
• 06975338701292: The product is used for 3D Printing dental try-in model.
• 06975338700400: CB21-B1
• 06975338700394: CB21-A3
• 06975338700387: CB21-A2
• 06975338700370: CB21-A1