| K-number | K243720 |
| Device name | 3Delta UNlimited |
| Applicant | Deltamed GmbH |
| Product code | EBF |
| Device class | Class II |
| Decision date | Dec 18, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 872.3690 |
3Delta UNlimited is a light-curing dental resin used to restore or improve chewing function by reconstructing damaged or missing teeth. It is designed for additively fabricated applications including permanent crowns, veneers, inlays, onlays, temporary crowns and bridges (maximum two consecutive pontics), monolithic full and partial dentures, and artificial denture teeth.
Not stated in this summary.
Not stated in this summary.
Not stated in this summary. The document indicates the device was found substantially equivalent to legally marketed predicate devices or devices reclassified prior to May 28, 1976, but does not provide the specific reasoning, predicate comparisons, or technical arguments supporting this determination. The actual justification would be contained in the referenced enclosure, which is not included in this document.
View the full FDA submission: accessdata.fda.gov