GUDID 16935835600426

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

Dental appliance fabrication material, thermoplastic

• Primary Device ID: 16935835600426
• NIH Device Record Key: 96e7da81-2ed3-4437-9bc4-a080f7c1ca87
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: HK-Y-CF-0.76
• 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	06935835600429 [Primary]
GS1	16935835600426 [Package]; Contains: 06935835600429; 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