# Genoss Co., Ltd.

- Location (FDA's records): Suwon-Si, KR
- FDA decisions: 23 (2007–2025): 23 510(k) clearances
- Names in FDA's records: Genoss Co., Ltd. (18); Genoss (5)
- Product codes: EIH (10), LYC (4), EBF (2), KIF (1), EKX (1), NPL (1), EBZ (1), KLE (1), ELB (1), ELW (1)
- 510(k) review time since 2016: median 273 days, against 187 for FDA's reviews in the same codes and years (1 of 14 faster)
- Predicates its devices cite: 25 (8 its own); citations of its devices by later devices: 13 (8 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
- GC America, Inc.: 2 (https://510kreport.com/company/gc-america)
- Biomatlante: 2 (https://510kreport.com/company/biomatlante)
- Ivoclar Vivadent, Inc.: 2 (https://510kreport.com/company/ivoclar-vivadent)
- Maruchi: 1 (https://510kreport.com/company/maruchi)
- Vident: 1 (https://510kreport.com/company/vident)
- Dms Co., Ltd.: 1 (https://510kreport.com/company/dms)
- Collagen Matrix, Inc.: 1 (https://510kreport.com/company/collagen-matrix)
- Organogenesis, Inc.: 1 (https://510kreport.com/company/organogenesis)

## Firms that cite its devices most
- DiaDent Group International: 2 (https://510kreport.com/company/diadent-group-international)
- Hudens Bio Co., Ltd.: 1 (https://510kreport.com/company/hudens-bio)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)
- Liaoning Upcera Co., Ltd.: 1 (https://510kreport.com/company/liaoning-upcera)

## Its most-cited devices
- K062834: Osteon, Models GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050 (2007), cited by 3
- K092513: Rainbow Block (2009), cited by 3
- K151731: Rainbow Paste Stain (2016), cited by 2
- K214086: Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty (2022), cited by 2
- K112716: Osteon II (2012), cited by 1
- K151842: Rainbow Shine (2016), cited by 1

## Recent decisions
- K242386: Bluemoon (May 5, 2025)
- K222688: The Trust (Aug 9, 2024)
- K233885: rainbow Paste Stain SE (Jun 21, 2024)
- K232174: rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono (Feb 23, 2024)
- K231480: Bright MTA Sealer Plus (Jul 28, 2023)
- K214086: Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty (Dec 15, 2022)
- K200155: Bright High Flow (Nov 30, 2020)
- K200153: Bright Bond Universal (Oct 28, 2020)

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