Ceramic Etchant

GUDID 06941382258822

Liaoning Upcera Co.,Ltd.

Dental etching solution

• Primary Device ID: 06941382258822
• NIH Device Record Key: 80c86cdc-fef2-4a15-8061-38a951ff3c58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceramic Etchant
• Version Model Number: HF-5 2.5ml
• Company DUNS: 548214192
• Company Name: Liaoning Upcera 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: 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	06941382258822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240153

FDA Product Code

• EIH: Powder, Porcelain

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: 2025-07-18
• Device Publish Date: 2025-07-10

Devices Manufactured by Liaoning Upcera Co.,Ltd.

• 06941382258822 - Ceramic Etchant: 2025-07-18
• 06941382258822 - Ceramic Etchant: 2025-07-18
• 06941382259478 - Gradual Dental Zirconia Blank: 2025-07-18
• 06941382260238 - Gradual Dental Zirconia Blank: 2025-07-18
• 06942201736125 - Tooth Shade Resin Material: 2025-07-10
• 06942201734367 - Tooth Shade Resin Material: 2025-06-25
• 06942201734374 - Tooth Shade Resin Material: 2025-06-25
• 06942201734381 - Tooth Shade Resin Material: 2025-06-25
• 06942201734398 - Tooth Shade Resin Material: 2025-06-25