# K213643: UltraPrint-Dental Temp C&B UV

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Heygears IMC., Inc.
- Decided: Jan 14, 2022 after 57 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: 4 generations back to K070991 (2007). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200273: FREEPRINT temp, Detax GmbH & Co. KG (2020) Summary page 5.

## Indications for use
UltraPrint-Dental Temp C&B UV is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment. Duration is not more than 28 days in oral environment.

Source page: https://510kreport.com/device/K213643
Methodology: https://510kreport.com/methodology