Dima Print Teeth & Temp
FDA 510(k)Class II (US FDA 510(k))
by Kulzer, LLC
Identifiers
- 510(k) Number
- K233868 FDA 510(k)
- FDA Product Code
- EBG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3770 FDA 510(k)
- Regulation Number
- 872.3770 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Dima Print Teeth & Temp is a CAD/CAM material designed for 3D printing dental indications, specifically teeth and temporaries. It allows for the fabrication of temporary crowns and bridges with high accuracy and mechanical properties.
This device is supplied for use with the cara printer to produce dental restorations. It has received FDA 510k clearance under the dental product code EBG.
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: dima® Print Teeth and Temp - kulzer.com, dima print - Kulzerus.com, PDF dima Print Teeth & Temp - kulzer.com, dima® Print Denture Teeth - Kulzer
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233868 | Class II | Active |
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Manufacturer
- Manufacturer
- Kulzer, LLC
Sources (1)
- FDA 510(k) K233868 24 fields · synced Sep 25, 2026