# Dreve Dentamid GmbH

- Location (FDA's records): Unna, DE
- FDA decisions: 6 (2017–2025): 6 510(k) clearances
- Product codes: ELW (2), EBI (1), NXC (1), EBG (1), EBD (1)
- 510(k) review time since 2016: median 259 days, against 126 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 4 (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
- Kettenbach GmbH & Co. KG: 1 (https://510kreport.com/company/kettenbach)
- Dentca, Inc.: 1 (https://510kreport.com/company/dentca)
- LuxCreo, Inc.: 1 (https://510kreport.com/company/luxcreo)
- Exacta Dental Products, Inc.: 1 (https://510kreport.com/company/exacta-dental-products)
- Exacta Dental Direct, Inc.: 1 (https://510kreport.com/company/exacta-dental-direct)
- Innovation Meditech GmbH: 1 (https://510kreport.com/company/innovation-meditech)

## Firms that cite its devices most
- Prevest Denpro Limited: 1 (https://510kreport.com/company/prevest-denpro)
- Dent4you AG: 1 (https://510kreport.com/company/dent4you)
- Ivoclar Vivadent, Inc.: 1 (https://510kreport.com/company/ivoclar-vivadent)
- Dreve Denatmid GmbH: 1 (https://510kreport.com/company/dreve-denatmid)

## Its most-cited devices
- K190571: StoneBite and StoneBite scan (2019), cited by 1
- K200580: FotoDent denture (2020), cited by 1
- K171562: Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono (2018), cited by 1
- K171729: Fixtemp C&B (2017), cited by 1

## Recent decisions
- K250739: Primeprint Direct Aligner (Nov 7, 2025)
- K200580: FotoDent denture (Nov 19, 2020)
- K190571: StoneBite and StoneBite scan (Nov 7, 2019)
- K171562: Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono (Apr 13, 2018)
- K162408: Nano Varnish, Plaquit, Lightpaint on Surface (Apr 5, 2018)
- K171729: Fixtemp C&B (Dec 13, 2017)

Source page: https://510kreport.com/company/dreve-dentamid