# K233868: dima Print Teeth & Temp

- Pathway: 510(k) (Traditional)
- Applicant: Kulzer, LLC
- Decided: May 23, 2024 after 169 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: 1 generation back to K172398 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192806: DENTCA Crown and Bridge, Dentca, Inc. (2020) Summary page 5.
- K172398: DENTCA DENTURE Teeth, Dentca, Inc. (2017) Summary page 5.

## Indications for use
Photopolymer for 3D printing of individualized, provisional and permanent prosthetic works. Indications - Long-term temporary restorations (up to 6 months), - Teeth for removable dentures

Source page: https://510kreport.com/device/K233868
Methodology: https://510kreport.com/methodology