# Dentis Co., Ltd.

- Location (FDA's records): Daegu, KR
- FDA decisions: 37 (2008–2026): 37 510(k) clearances
- Product codes: DZE (19), NHA (13), EBG (1), NXC (1), DZL (1), KLC (1), EKX (1)
- 510(k) review time since 2016: median 128 days, against 182 for FDA's reviews in the same codes and years (22 of 29 faster)
- Predicates its devices cite: 57 (33 its own); citations of its devices by later devices: 47 (33 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
- Osstem Implant Co., Ltd.: 5 (https://510kreport.com/company/osstem-implant)
- Megagen Co., Ltd.: 3 (https://510kreport.com/company/megagen)
- Dio Corporation: 3 (https://510kreport.com/company/dio)
- Megagen Implant Co., Ltd.: 2 (https://510kreport.com/company/megagen-implant)
- Dio Department Dsi, Inc.: 2 (https://510kreport.com/company/dio-department-dsi)
- Deltamed GmbH: 1 (https://510kreport.com/company/deltamed)
- Izenimplant Co., Ltd.: 1 (https://510kreport.com/company/izenimplant)
- Ensmile Pvt, Ltd.: 1 (https://510kreport.com/company/ensmile-pvt)

## Firms that cite its devices most
- Innobiosurg Co., Ltd.: 2 (https://510kreport.com/company/innobiosurg)
- Mipont Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/mipont-medical-equipment)
- Ossvis Co., Ltd.: 1 (https://510kreport.com/company/ossvis)
- Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.: 1 (https://510kreport.com/company/ags-medikal-urunleri-ith-ihr-tic-sti)
- Arum Dentistry Co., Ltd.: 1 (https://510kreport.com/company/arum-dentistry)
- Detax GmbH & Co. KG: 1 (https://510kreport.com/company/detax)
- Izenimplant Co., Ltd.: 1 (https://510kreport.com/company/izenimplant)
- Megagen Implant Co., Ltd.: 1 (https://510kreport.com/company/megagen-implant)

## Its most-cited devices
- K153639: OneQ-SL s-Clean Implant System (2016), cited by 7
- K161244: s-Clean OneQ-SL Narrow Implant System (2016), cited by 6
- K171027: Dentis Dental Implant System (2017), cited by 5
- K150344: Dentis Dental Implant System (2015), cited by 5
- K073486: Dentis Dental Implant System (2008), cited by 5
- K192688: s-Clean SQ-SL Implant System Regular (2020), cited by 3

## Recent decisions
- K253493: Dentis SQ-SL AXEL Fixture (Mar 4, 2026)
- K241065: ChecQ (AC100) (Mar 21, 2025)
- K233921: Luvis Chair (LC700C) (Sep 6, 2024)
- K241063: s-Clean ScanHealing Abutment (Jul 25, 2024)
- K240511: Dentis s-Clean SQ-SL Fixture (May 20, 2024)
- K233544: Mesheet (Feb 22, 2024)
- K230126: Dentis s-Clean Regular Abutment (Aug 4, 2023)
- K230307: Dentis i-Clean System (Jul 11, 2023)

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