DentaTOOTH

GUDID 09359215000109

DentaTOOTH is a resin material used by dental professionals for the manufacture of temporary dental restorations including temporary crowns, bridges, inlays, onlays and veneers. DentaTOOTH resin is available in six Vita shades A1, A2, A3, B1, B2, B3. DentaTOOTH resins are used with digital light processing (DLP) based 3D printers to produce temproary dental restorations. DentaTOOTH has been validated for use with the Asiga Max and Pro Series printers for manufacture of temporary dental resins at 385nm wavelengths.

ASIGA PTY LTD

Dental appliance fabrication material, resin

• Primary Device ID: 09359215000109
• NIH Device Record Key: 2036026f-925d-414b-b314-b419fab6dcd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DentaTOOTH
• Version Model Number: 03624
• Company DUNS: 745954045
• Company Name: ASIGA PTY 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09359215000109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243370

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

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: 2025-05-20
• Device Publish Date: 2025-05-12

Devices Manufactured by ASIGA PTY LTD

• 09359215000109 - DentaTOOTH: 2025-05-20DentaTOOTH is a resin material used by dental professionals for the manufacture of temporary dental restorations including temporary crowns, bridges, inlays, onlays and veneers. DentaTOOTH resin is available in six Vita shades A1, A2, A3, B1, B2, B3. DentaTOOTH resins are used with digital light processing (DLP) based 3D printers to produce temproary dental restorations. DentaTOOTH has been validated for use with the Asiga Max and Pro Series printers for manufacture of temporary dental resins at 385nm wavelengths.
• 09359215000109 - DentaTOOTH: 2025-05-20 DentaTOOTH is a resin material used by dental professionals for the manufacture of temporary dental restorations including tempo
• 09359215000369 - DentaBASE: 2025-04-25 Asiga DentaBASE resins are used with digital light processing (DLP) based 3D printers to produce denture bases. DentaBASE resin
• 09359215000031 - DentaGUIDE: 2024-02-14
• 09359215000055 - DentaIBT: 2024-02-14
• 09359215000093 - DentaTRAY: 2024-02-14
• 09359215000161 - DentaTRY A1: 2024-02-14
• 09359215000178 - DentaTRY A2: 2024-02-14
• 09359215000185 - DentaTRY A3: 2024-02-14