# DiaDent Group International

- Location (FDA's records): Cheongju-Si, KR
- FDA decisions: 24 (2013–2026): 24 510(k) clearances
- Product codes: KIF (6), EBF (5), KLE (4), ELW (3), EBG (2), EMA (2), EBZ (2)
- 510(k) review time since 2016: median 179 days, against 194 for FDA's reviews in the same codes and years (10 of 22 faster)
- Predicates its devices cite: 31 (6 its own); citations of its devices by later devices: 14 (6 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
- Vericom Co., Ltd.: 4 (https://510kreport.com/company/vericom)
- Bisco, Inc.: 3 (https://510kreport.com/company/bisco)
- Meta Biomed Co., Ltd.: 3 (https://510kreport.com/company/meta-biomed)
- Neodental Chemical Products Co., Ltd.: 2 (https://510kreport.com/company/neodental-chemical-products)
- Genoss Co., Ltd.: 2 (https://510kreport.com/company/genoss)
- Innovative Product Brands, Inc.: 2 (https://510kreport.com/company/innovative-product-brands)
- Voco GmbH: 1 (https://510kreport.com/company/voco)
- Mycone Dental Supply Co., Inc.: 1 (https://510kreport.com/company/mycone-dental-supply)

## Firms that cite its devices most
- Ultradent Products, Inc.: 2 (https://510kreport.com/company/ultradent-products)
- Meta Biomed Co., Ltd.: 1 (https://510kreport.com/company/meta-biomed)
- Genoss Co., Ltd.: 1 (https://510kreport.com/company/genoss)
- Guilin Refine Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/guilin-refine-medical-instrument)
- Changzhou Sifary Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/changzhou-sifary-medical-technology)
- Foshan Coxo Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/foshan-coxo-medical-instrument)
- Mediclus Co., Ltd.: 1 (https://510kreport.com/company/mediclus)

## Its most-cited devices
- K200809: D-LUX+ (2020), cited by 4
- K192510: DIAFIL & DIAFIL Capsule (2020), cited by 2
- K213401: DIAPLUS Universal (2022), cited by 1
- K182625: Diapex Plus (2019), cited by 1
- K192273: DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit (2020), cited by 1
- K231552: Dia-Cem (2023), cited by 1

## Recent decisions
- K254152: Dia-X Sil Light Body (Sep 16, 2026)
- K254142: Dia-X Sil Heavy Body (Sep 16, 2026)
- K261166: Dia-Cem (Jul 9, 2026)
- K261093: Diafil (Jun 2, 2026)
- K261071: DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) (May 19, 2026)
- K254112: Dia-X Sil Bite (Mar 19, 2026)
- K231552: Dia-Cem (Jul 28, 2023)
- K220804: Dia-X Bond Universal (Jun 15, 2022)

Source page: https://510kreport.com/company/diadent-group-international