Cerawhite

GUDID 06975409644008

Hangzhou Thales Medtech Co., Ltd.

Complete upper denture

• Primary Device ID: 06975409644008
• NIH Device Record Key: 77e95359-a2ab-4192-aefa-1a5ffe2590cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cerawhite
• Version Model Number: porcelain-crown/bridge
• Company DUNS: 841846639
• Company Name: Hangzhou Thales Medtech Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	06975409644008 [Primary]

FDA Product Code

• ELJ: Teeth, Artificial, Posterior With Metal Insert

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[06975409644008]

Moist Heat or Steam Sterilization

[06975409644008]

Moist Heat or Steam Sterilization

[06975409644008]

Moist Heat or Steam Sterilization

[06975409644008]

Moist Heat or Steam Sterilization

[06975409644008]

Moist Heat or Steam Sterilization

[06975409644008]

Moist Heat or Steam Sterilization

[06975409644008]

Moist Heat or Steam Sterilization

[06975409644008]

Moist Heat or Steam Sterilization

[06975409644008]

Moist Heat or Steam Sterilization

[06975409644008]

Moist Heat or Steam Sterilization

[06975409644008]

Moist Heat or Steam Sterilization

[06975409644008]

Moist Heat or Steam Sterilization

[06975409644008]

Moist Heat or Steam Sterilization

[06975409644008]

Moist Heat or Steam Sterilization

[06975409644008]

Moist Heat or Steam Sterilization

[06975409644008]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-23
• Device Publish Date: 2023-05-15

On-Brand Devices [Cerawhite]

• 06975409644008: porcelain-crown/bridge
• 06975409643001: crown/bridge
• 06975409642004: porcelain-veneer