# K180657: Resin for Temporary Crown & Bridge

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: Dec 7, 2018 after 269 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
Longest line of descent: 2 generations back to K070991 (2007). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102776: Extra-Oral, Additive Computer Aided Manufacture and Curing System, Deltamed GmbH (2011) Summary page 4.

## Most influential descendants
- K200273: FREEPRINT temp (2020), 1 descendant of its own
- K213643: UltraPrint-Dental Temp C&B UV (2022), 0 descendants of its own
- K210817: C&B 5.0 Hybrid (2021), 0 descendants of its own
- K193113: GC Temp Print (2020), 0 descendants of its own

## Indications for use
Resin for Temporary Crown & Bridge is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment. Duration is less than 30 days in oral environment.

Source page: https://510kreport.com/device/K180657
Methodology: https://510kreport.com/methodology