# Dent4you AG

- Location (FDA's records): Heerbrugg, CH
- FDA decisions: 5 (2022–2026): 5 510(k) clearances
- Names in FDA's records: Dent4you AG (4); Dent4You AG (1)
- Product codes: ELW (2), ELC (1), EBZ (1), KLE (1)
- 510(k) review time since 2016: median 89 days, against 101 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Coltene/Whaledent, Inc.: 3 (https://510kreport.com/company/coltene-whaledent)
- Dreve Dentamid GmbH: 1 (https://510kreport.com/company/dreve-dentamid)

## Recent decisions
- K263680: One Coat Bond; One Coat Bond SL (Oct 8, 2026)
- K250969: Jet Bite; Jet Blue Bite Fast; Jet Blue Bite Superfast (Jun 27, 2025)
- K242360: Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator (Nov 15, 2024)
- K240801: BioSonic US200 Ultrasonic Scaler (60034537) (Jul 1, 2024)
- K223142: Coltolux Comfort LED Curing Light (Dec 22, 2022)

Source page: https://510kreport.com/company/dent4you