DentaBASE

GUDID 09359215000369

Asiga DentaBASE resins are used with digital light processing (DLP) based 3D printers to produce denture bases. DentaBASE resin has been validated for use with the Asiga Max Series and Pro Series printers. Asiga DentaBASE is a Type 4 light-cure methacrylate-based resin with photoinitiator, UV absorber, dispersant and pigments. Asiga DentaBASE resin material is used in a DLP 3D printer, which prints the denture base from CAD data. The denture base is built by solidifying successive layers of photopolymer against eachother. Each layer is light cured before adding the next layer, with post-curing in a light chamber unit. The 3D printer and light-curing unit are not included with the device. The device is supplied as a pre-mixed resin in one color, natural pink. The device is supplied non-sterile, and it is not intended to be sterilised.

ASIGA PTY LTD

Dental appliance fabrication material, resin

• Primary Device ID: 09359215000369
• NIH Device Record Key: dd95df6d-1c87-4b8b-a66d-69721ac513dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DentaBASE
• Version Model Number: 03569
• 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	09359215000369 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243356

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2025-04-25
• Device Publish Date: 2025-04-17

Devices Manufactured by ASIGA PTY LTD

• 09359215000369 - DentaBASE: 2025-04-25Asiga DentaBASE resins are used with digital light processing (DLP) based 3D printers to produce denture bases. DentaBASE resin has been validated for use with the Asiga Max Series and Pro Series printers. Asiga DentaBASE is a Type 4 light-cure methacrylate-based resin with photoinitiator, UV absorber, dispersant and pigments. Asiga DentaBASE resin material is used in a DLP 3D printer, which prints the denture base from CAD data. The denture base is built by solidifying successive layers of photopolymer against eachother. Each layer is light cured before adding the next layer, with post-curing in a light chamber unit. The 3D printer and light-curing unit are not included with the device. The device is supplied as a pre-mixed resin in one color, natural pink. The device is supplied non-sterile, and it is not intended to be sterilised.
• 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
• 09359215000192 - DentaTRY B1: 2024-02-14