# Neobiotech Co., Ltd.

- Location (FDA's records): Seoul, KR
- FDA decisions: 17 (2004–2024): 17 510(k) clearances
- Product codes: DZE (13), NHA (2), DZL (1), JEY (1)
- 510(k) review time since 2016: median 156 days, against 200 for FDA's reviews in the same codes and years (5 of 9 faster)
- Predicates its devices cite: 30 (8 its own); citations of its devices by later devices: 37 (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
- Osstem Implant Co., Ltd.: 9 (https://510kreport.com/company/osstem-implant)
- Implant Innovations, Inc.: 2 (https://510kreport.com/company/implant-innovations)
- Megagen Co., Ltd.: 2 (https://510kreport.com/company/megagen)
- Dio Department Dsi, Inc.: 2 (https://510kreport.com/company/dio-department-dsi)
- Paltop Advanced Dental Solutions, Ltd.: 1 (https://510kreport.com/company/paltop-advanced-dental-solutions)
- Implant Innovations International, Inc.: 1 (https://510kreport.com/company/implant-innovations-international)
- Jeil Medical Corporation: 1 (https://510kreport.com/company/jeil-medical)
- Implant Direct, LLC: 1 (https://510kreport.com/company/implant-direct)

## Firms that cite its devices most
- Cowellmedi Co., Ltd.: 4 (https://510kreport.com/company/cowellmedi)
- Osstem Implant Co., Ltd.: 3 (https://510kreport.com/company/osstem-implant)
- Snucone Co., Ltd.: 2 (https://510kreport.com/company/snucone)
- Csm Implant: 2 (https://510kreport.com/company/csm-implant)
- Arum Dentistry Co., Ltd.: 2 (https://510kreport.com/company/arum-dentistry)
- Izenimplant Co., Ltd.: 2 (https://510kreport.com/company/izenimplant)
- Cotec Implant Co., Ltd.: 2 (https://510kreport.com/company/cotec-implant)
- Innobiosurg Co., Ltd.: 1 (https://510kreport.com/company/innobiosurg)

## Its most-cited devices
- K181138: IS-III active System (2018), cited by 11
- K090825: SQ IS System (2009), cited by 5
- K111761: Neo Titanium Mesh, Cti-Mem (2012), cited by 4
- K113554: Cmi Implant IS System (2012), cited by 4
- K112540: S-Mini Implant System (2012), cited by 4
- K090527: Sinus Quick IT System (2009), cited by 3

## Recent decisions
- K232528: Protective Cap (Apr 30, 2024)
- K232049: IS-III active Short Implant (Mar 28, 2024)
- K210903: IS Multi Unit Abutment System (Jul 23, 2021)
- K190849: IS-III active System_S-narrow Type (Aug 14, 2019)
- K181137: IT-III active System (Nov 16, 2018)
- K181138: IS-III active System (Oct 3, 2018)
- K181178: S-mini active Fixture (Jul 24, 2018)
- K173938: IS-III HActive Fixture (May 24, 2018)

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