# K192806: DENTCA Crown and Bridge

- Pathway: 510(k) (Traditional)
- Applicant: Dentca, Inc.
- Decided: Feb 5, 2020 after 127 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K243336: Lucitone Digital Print Denture™ System (2024), 0 descendants of its own
- K233868: dima Print Teeth & Temp (2024), 0 descendants of its own

## Indications for use
DENTCA Crown and Bridge is a light-curable polymerizable resin to fabricate, by additive manufacturing, temporary crowns or bridges. The fabricated temporary crowns or bridges are an alternative to preformed temporary crowns or bridges. The fabrication of temporary crowns or bridges with DENTCA Crown and Bridge requires digital models of crowns or bridges, a stereolithographic additive printer, and curing light equipment.

Source page: https://510kreport.com/device/K192806
Methodology: https://510kreport.com/methodology