# K240538: Premium Teeth Resin

- Pathway: 510(k) (Traditional)
- Applicant: Formlabs Ohio, Inc.
- Decided: Jul 19, 2024 after 144 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 K193553 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193553: VarseoSmile Temp, Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG (2020) Summary page 5.

## Indications for use
Premium Teeth Resin, when utilized to print 3D printed dental appliances such as denture teeth for complete and partial removable dentures, try-in dentures, provisional full arch implant-supported restoration and provisional restorations such as temporary crowns and bridges, inlays, onlays and veneers, is indicated to replace or restore missing tooth structures or missing teeth.

Source page: https://510kreport.com/device/K240538
Methodology: https://510kreport.com/methodology