Zirconia Porcelain

GUDID 06973133310206

It is indicated for use for metal-ceramic full veneers and partial veneers and for zirconia full veneers and partial veneers.

BAOT Biological Technology Co., Ltd.

Dental appliance fabrication material, ceramic

• Primary Device ID: 06973133310206
• NIH Device Record Key: 83196c55-88f4-4ff4-9af0-198cb7214947
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zirconia Porcelain
• Version Model Number: Standard Kit
• Company DUNS: 560453518
• Company Name: BAOT Biological Technology Co., Ltd.
• Device Count: 1
• DM Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973133310206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182350

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: 2020-05-22
• Device Publish Date: 2020-05-14

Devices Manufactured by BAOT Biological Technology Co., Ltd.

• 06973133314235 - BAOT®: 2024-08-29 Dental Ceramic is indicated for use for metal-ceramic full veneers and partial veneers and for zirconia full veneers and partial
• 06973133314280 - BAOT®: 2024-08-28 Dental Ceramic is indicated for use for metal-ceramic full veneers and partial veneers and for zirconia full veneers and partial
• 06973133313726 - BAOT®: 2023-08-07 Dental Ceramic is indicated for use for metal-ceramic full veneers and partial veneers and for zirconia full veneers and partial
• 06973133312583 - BAOT: 2023-07-10 Dental Ceramic is indicated for use for metal-ceramic full veneers and partial veneers and for zirconia full veneers and partial
• 06973133312392 - BAOT: 2022-07-22
• 06973133312408 - BAOT: 2022-07-22
• 06973133312415 - BAOT: 2022-07-22
• 06973133312422 - BAOT: 2022-07-22