# Detax GmbH & Co. KG

- Location (FDA's records): Ettingen, DE
- FDA decisions: 8 (2000–2025): 8 510(k) clearances
- Names in FDA's records: Detax GmbH & Co. KG (5); Detax GmbH (3)
- Product codes: EBI (3), EBG (2), MQC (1), EBF (1), EMA (1)
- 510(k) review time since 2016: median 131 days, against 195 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 6 (1 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
- Pro3Dure Medical GmbH: 1 (https://510kreport.com/company/pro3dure-medical)
- Keystone Industries: 1 (https://510kreport.com/company/keystone-industries)
- Mycone Dental Supply Co. Inc. (Dba Keystone Industries): 1 (https://510kreport.com/company/mycone-dental-supply-co-dba-keystone-industries)
- Graphy, Inc.: 1 (https://510kreport.com/company/graphy)
- Dentis Co., Ltd.: 1 (https://510kreport.com/company/dentis)
- Vertex-Dental B.V.: 1 (https://510kreport.com/company/vertex-dental)

## Firms that cite its devices most
- Guangzhou Heygears IMC., Inc.: 2 (https://510kreport.com/company/guangzhou-heygears-imc)
- Aidite (Qinhuangdao) Technology Co., Ltd.: 2 (https://510kreport.com/company/aidite-qinhuangdao-technology)
- Hangzhou SHINING3D Dental Technology Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-shining3d-dental-technology)

## Its most-cited devices
- K200461: Freeprint denture (2020), cited by 3
- K222877: FREEPRINT crown (2022), cited by 2
- K200273: FREEPRINT temp (2020), cited by 1

## Recent decisions
- K252430: Freeprint® denture flex (Oct 30, 2025)
- K232448: FREEPRINT® splintmaster (Oct 12, 2023)
- K222877: FREEPRINT crown (Sep 23, 2022)
- K200461: Freeprint denture (Nov 16, 2020)
- K200273: FREEPRINT temp (Oct 27, 2020)
- K162654: mollosil plus (Mar 13, 2017)
- K100247: Detax Implantlink Semi (Jul 23, 2010)
- K994012: Tempofit, Model 02693 (Feb 16, 2000)

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