# K243370: DentaTOOTH

- Pathway: 510(k) (Traditional)
- Applicant: Asiga Pty, Ltd.
- Decided: May 5, 2025 after 187 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 K924830 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211101: E-Temp, Envisiontec GmbH (2021) Summary page 5.
- K200039: P pro Crown & Bridge, Deltamed GmbH (2020) Summary page 5.

## Indications for use
Asiga DentaTOOTH is intended exclusively for professional dental work. Asiga DentaTOOTH is a 3D print resin indicated for the manufacturing of 3D printed temporary crowns, bridges, inlays, onlays and veneers.

Source page: https://510kreport.com/device/K243370
Methodology: https://510kreport.com/methodology