# Dentium Co., Ltd.

- Location (FDA's records): Yongin-Si, KR
- FDA decisions: 23 (2004–2022): 23 510(k) clearances
- Names in FDA's records: Dentium Co., Ltd. (22); Dentium, Inc. (1)
- Product codes: NHA (13), DZE (9), EBW (1)
- 510(k) review time since 2016: median 176 days, against 202 for FDA's reviews in the same codes and years (7 of 12 faster)
- Predicates its devices cite: 33 (20 its own); citations of its devices by later devices: 50 (20 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Astra Tech, Inc.: 2 (https://510kreport.com/company/astra-tech)
- Nobel Biocare Uas, Inc.: 2 (https://510kreport.com/company/nobel-biocare-uas)
- Imtec Corp.: 1 (https://510kreport.com/company/imtec)
- Jeil Medical Corporation: 1 (https://510kreport.com/company/jeil-medical)
- Kaltenbach & Voigt GmbH: 1 (https://510kreport.com/company/kaltenbach-voigt)
- Jjgc Industria E Comercio DE Materiais Dentarios S: 1 (https://510kreport.com/company/jjgc-industria-e-comercio-de-materiais-dentarios-s)
- Nobel Biocare AB: 1 (https://510kreport.com/company/nobel-biocare)
- Medentika GmbH: 1 (https://510kreport.com/company/medentika)

## Firms that cite its devices most
- Warantec Co., Ltd.: 6 (https://510kreport.com/company/warantec)
- Unidental Co., Ltd.: 3 (https://510kreport.com/company/unidental)
- Syntec Scientific Corp.: 2 (https://510kreport.com/company/syntec-scientific)
- Cowellmedi Co., Ltd.: 2 (https://510kreport.com/company/cowellmedi)
- DIMPLO, Ltd.: 2 (https://510kreport.com/company/dimplo)
- Achimhai Medical Corporation: 2 (https://510kreport.com/company/achimhai-medical)
- Shinhung Mst Co., Ltd.: 2 (https://510kreport.com/company/shinhung-mst)
- Proimtech Saglik Urunleri Anonim Sirketi: 1 (https://510kreport.com/company/proimtech-saglik-urunleri-anonim-sirketi)

## Its most-cited devices
- K052957: Implantium Prosthetics (2006), cited by 10
- K041368: Dentium CO., LTD. Implantium (2004), cited by 10
- K112045: Simpleline II Abutment System (2012), cited by 5
- K052823: Implantium Abutments (2006), cited by 5
- K060501: Implantium II (2006), cited by 4
- K141457: Dentium Implantium and Superline Abutments (2014), cited by 4

## Recent decisions
- K213599: SuperLine (Feb 23, 2022)
- K193341: iCTmotor (WL-1) (Sep 4, 2020)
- K192436: Healing Abutments and Cover Screws (Jan 23, 2020)
- K191634: Scan Abutments and Comfort Caps (Nov 4, 2019)
- K172640: Dentium Implantium & SuperLine Prosthetics (May 14, 2018)
- K171622: Dentium Ti-Base (Jan 11, 2018)
- K171126: Implantium II (Sep 7, 2017)
- K170384: Dentium NR Line CAD/CAM Abutments (Aug 17, 2017)

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