3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212541 FDA 510(k)
- FDA Product Code
- EBI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3760 FDA 510(k)
- Regulation Number
- 872.3760 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This is a denture base resin system designed for additive manufacturing of full and partial denture bases, along with bonding and luting components. The 3Delta Denture Base is a light-curing resin formulated for high aesthetic reproduction, while the 3Delta Denture Bond and 3Delta Denture Fix provide a secure adhesive interface between the base and denture teeth. The system is intended for use in dental laboratories and clinical settings requiring custom-fabricated prosthetics.
The 3Delta Denture Base is supplied in pink opaque (1000 g) and pink transparent (1000 g) formulations, with the bonding agents provided as 3Delta Denture Bond (10 ml) and 3Delta Denture Fix (8 g). The system is sterilised by gamma irradiation and intended for single-use per application, though the base resin may be processed in a controlled laboratory environment. No MRI safety classifications or reusable components are specified. Authorised under FDA 510(k) clearance (K212541), the system adheres to dental product regulations for prosthetics.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Full Denture - 3D Resins Medical - DeltaMed, DeltaMed - Zahnmedizin - Zahntechnik - 3D Druck - Projekte OEM/Private ..., 3Delta Denture Base / DeltaMed GmbH, 3Delta Denture Bond & Fix / DeltaMed GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212541 | Class II | Active |
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Manufacturer
- Manufacturer
- DeltaMed GmbH
Sources (1)
- FDA 510(k) K212541 24 fields · synced Sep 19, 2026