DentaBASE
Basic Information
- Brand Name
- DentaBASE
- Primary DI
- 09359215000369
- Version / Model
- 03569
- Company Name
- ASIGA PTY LTD
- Labeler DUNS
- 745954045
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-17
- Public Version
- 1
- Public Version Date
- 2025-04-25
- Public Version Status
- New
- Public Device Record Key
- dd95df6d-1c87-4b8b-a66d-69721ac513dd
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16730 | Dental appliance fabrication material, resin | A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09359215000369 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243356 | 000 |