Identity
- Trade Name
- DentaBASE EUDAMEDFDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- DentaBASE EUDAMEDAsiga 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. FDA UDI
- Model / Reference
- 03569 EUDAMEDFDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09359215000369 EUDAMEDFDA UDI
- Basic UDI-DI
- 93592150BASER3 EUDAMED
- 510(k) Number
- K243356 FDA UDI
- FDA Product Code
- EBI FDA UDI
- EMDN Code
- Q0102050199 DENTISTRY RESINS - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3760 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
DentaBASE by Asiga — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 93592150BASER3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Asiga
- EUDAMED SRN
- AU-MF-000012099
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED cb043574-6c74-48d2-b49b-88b8c1785ffd 61 fields · synced Jul 10, 2026
- FDA UDI dd95df6d-1c87-4b8b-a66d-69721ac513dd 34 fields · synced May 30, 2026