Zrcoop

GUDID 06975409641007

Additive Manufacturing Zirconia Customized Restoration is indicated for use as the core structure of prostheses for partially edentulous patients in need of prosthetic oral reconstruction to restore chewing function and aesthetics. The Additive Manufacturing Zirconia Customized Restoration is a premanufactured prosthetic component and is indicated for use as restorations (Crown,Bridge,Veneer,Inlay) that will be cemented to a natural or artificial tooth abutment.

Hangzhou Thales Medtech Co., Ltd.

Complete upper denture

• Primary Device ID: 06975409641007
• NIH Device Record Key: 23a0028f-b478-483f-960a-32a3e769e343
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zrcoop
• Version Model Number: Additive manufacturing of zirconia porcelain crown
• Company DUNS: 841846639
• Company Name: Hangzhou Thales Medtech 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: true
• Lot Batch: true
• Serial Number: true
• 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	06975409641007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240586

FDA Product Code

• ELL: Teeth, Porcelain

Sterilization

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

[06975409641007]

Moist Heat or Steam Sterilization

[06975409641007]

Moist Heat or Steam Sterilization

[06975409641007]

Moist Heat or Steam Sterilization

[06975409641007]

Moist Heat or Steam Sterilization

[06975409641007]

Moist Heat or Steam Sterilization

[06975409641007]

Moist Heat or Steam Sterilization

[06975409641007]

Moist Heat or Steam Sterilization

[06975409641007]

Moist Heat or Steam Sterilization

[06975409641007]

Moist Heat or Steam Sterilization

[06975409641007]

Moist Heat or Steam Sterilization

[06975409641007]

Moist Heat or Steam Sterilization

[06975409641007]

Moist Heat or Steam Sterilization

[06975409641007]

Moist Heat or Steam Sterilization

[06975409641007]

Moist Heat or Steam Sterilization

[06975409641007]

Moist Heat or Steam Sterilization

[06975409641007]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-13
• Device Publish Date: 2025-01-03

On-Brand Devices [Zrcoop]

• 06975409641007: Additive Manufacturing Zirconia Customized Restoration is indicated for use as the core structu
• 06975409640079: Additive Manufacturing Zirconia Customized Restoration is indicated for use as the core st
• 06975409640062: Additive Manufacturing Zirconia Customized Restoration is indicated for use as the core structur
• 06975409640055: Additive Manufacturing Zirconia Customized Restoration is indicated for use as the core structur