GUDID 16935835600402

Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.

Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic

• Primary Device ID: 16935835600402
• NIH Device Record Key: 21c3de15-31c5-4710-8206-c517dcb37dec
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: HK-Y-0.7
• Company DUNS: 410789418
• Company Name: Hkable 3D Biologic Printing Technology(Chongqing) 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	06935835600405 [Primary]
GS1	16935835600402 [Package]; Contains: 06935835600405; Package: [35 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230237

FDA Product Code

• KMY: Positioner, Tooth, Preformed

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: 2023-10-17
• Device Publish Date: 2023-10-09

Devices Manufactured by Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.

• 16935835600006 - NA: 2023-10-17
• 16935835600211 - NA: 2023-10-17
• 16935835600228 - NA: 2023-10-17
• 16935835600280 - NA: 2023-10-17
• 16935835600303 - NA: 2023-10-17
• 16935835600334 - NA: 2023-10-17
• 16935835600341 - NA: 2023-10-17
• 16935835600358 - NA: 2023-10-17