Medical Device Manufacturer · US , Newington , NH

Cowellmedi Co., Ltd.

14 submissions · 14 cleared · Since 2004
14
Total
14
Cleared
0
Denied

Cowellmedi Co., Ltd. — FDA 510(k) Submissions

Cowellmedi Co., Ltd. has submitted 14 FDA 510(k) premarket notifications since 2004, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Implant, Endosseous, Root-form, Abutment, Implant, Dental, Endosseous, Barrier, Synthetic, Intraoral . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
SFIT Abutment
K242287 · NHA Abutment, Implant,... · Dental
Sep 2025 410d
INNO SLA Mini Plus? Implant System
K241127 · DZE Implant, Endosseous,... · Dental
Dec 2024 248d
INNO SLA Submerged Hybrid Ti-Base System
K231411 · NHA Abutment, Implant,... · Dental
Dec 2023 218d
Meta G UCLA Abutment
K232546 · NHA Abutment, Implant,... · Dental
Nov 2023 90d
INNO SLA Submerged Narrow Implant System
K231395 · DZE Implant, Endosseous,... · Dental
Oct 2023 156d
InnoGenic Non-resorbable Membrane
K211554 · NPK Barrier, Synthetic,... · Dental
Feb 2023 646d
INNO SLA Submerged Implant System
K201323 · NHA Abutment, Implant,... · Dental
Jan 2022 617d
INNO SLA SUBMERGED IMPLANT SYSTEM
K132242 · DZE Implant, Endosseous,... · Dental
Dec 2013 141d
COWELL IMPLANT SYSTEM
K100850 · DZE Implant, Endosseous,... · Dental
Dec 2010 269d
ATLAS IMPLANT SYSTEM - WIDE PLUS
K090054 · DZE Implant, Endosseous,... · Dental
Jul 2009 202d
ATLAS IMPLANT SYSTEM- MINI PLUS
K090049 · DZE Implant, Endosseous,... · Dental
Apr 2009 103d
ATLAS IMPLANT SYSTEM
K071148 · DZE Implant, Endosseous,... · Dental
Feb 2008 288d
ALLFIM IMPLANT SYSTEMS
K050635 · DZE Implant, Endosseous,... · Dental
Jul 2005 119d
BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)
K041655 · DZE Implant, Endosseous,... · Dental
Sep 2004 82d
Filters
All14 Dental 14