Dentitude

GUDID 26976146410097

Fuzhou Rick Brown Biomaterials Co. Ltd.

Dental appliance fabrication material, ceramic

• Primary Device ID: 26976146410097
• NIH Device Record Key: aed797f2-e9ad-4e9e-9689-615425fdf4db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dentitude
• Version Model Number: HT-C1/L-18-15-13
• Company DUNS: 416486948
• Company Name: Fuzhou Rick Brown Biomaterials Co. Ltd.
• Device Count: 5
• 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: false
• Expiration Date: false
• 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	06976146410093 [Primary]
GS1	16976146410090 [Unit of Use]
GS1	26976146410097 [Package]; Contains: 06976146410093; Package: [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230487

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: 2024-04-01
• Device Publish Date: 2024-03-22

On-Brand Devices [Dentitude]

• 26976146410004: HT-A1/L-18-15-13
• 06976146410017: HT-A2/L-18-15-13
• 26976146410646: HT-A4/D-13-10
• 26976146410639: HT-A3.5/D-13-10
• 26976146410622: HT-A3/D-13-10
• 26976146410615: HT-A2/D-13-10
• 26976146410608: HT-A1/D-13-10
• 26976146410592: LT-BL4/L-18-15-13
• 26976146410585: LT-BL3/L-18-15-13
• 26976146410578: LT-BL2/L-18-15-13
• 26976146410554: LT-D4/L-18-15-13
• 26976146410547: LT-D3/L-18-15-13
• 26976146410530: LT-D2/L-18-15-13
• 26976146410523: LT-C4/L-18-15-13
• 26976146410516: LT-C3/L-18-15-13
• 26976146410509: LT-C2/L-18-15-13
• 26976146410493: LT-C1/L-18-15-13
• 26976146410486: LT-B4/L-18-15-13
• 26976146410479: LT-B3/L-18-15-13
• 26976146410462: LT-B2/L-18-15-13
• 26976146410455: LT-B1/L-18-15-13
• 26976146410448: LT-A4/L-18-15-13
• 26976146410431: LT-A3.5/L-18-15-13
• 26976146410424: LT-A3/L-18-15-13
• 26976146410417: LT-A2/L-18-15-13
• 26976146410400: LT-A1/L-18-15-13
• 26976146410394: MT-BL4/L-18-15-13
• 26976146410387: MT-BL3/L-18-15-13
• 26976146410370: MT-BL2/L-18-15-13
• 26976146410363: MT-BL1/L-18-15-13
• 26976146410356: MT-D4/L-18-15-13
• 26976146410349: MT-D3/L-18-15-13
• 26976146410332: MT-D2/L-18-15-13
• 26976146410325: MT-C4/L-18-15-13
• 26976146410318: MT-C3/L-18-15-13
• 26976146410301: MT-C2/L-18-15-13
• 26976146410295: MT-C1/L-18-15-13
• 26976146410288: MT-B4/L-18-15-13
• 26976146410271: MT-B3/L-18-15-13
• 26976146410264: MT-B2/L-18-15-13
• 26976146410257: MT-B1/L-18-15-13
• 26976146410240: MT-A4/L-18-15-13
• 26976146410233: MT-A3.5/L-18-15-13
• 26976146410226: MT-A3/L-18-15-13
• 26976146410219: MT-A2/L-18-15-13
• 26976146410202: MT-A1/L-18-15-13
• 26976146410196: HT-BL4/L-18-15-13
• 26976146410189: HT-BL3/L-18-15-13
• 26976146410172: HT-BL2/L-18-15-13
• 26976146410165: HT-BL1/L-18-15-13