Medical Device Manufacturer · US , Newington , NH

Cowellmedi Co., Ltd. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2004

Recent clearances: SFIT Abutment, INNO SLA Mini Plus® Implant System, INNO SLA Submerged Hybrid Ti-Base System

14
Total
14
Cleared
0
Denied

FDA 510(k) Regulatory Record - Cowellmedi Co., Ltd. Dental ✕

14 devices
1-14 of 14
Cleared Sep 16, 2025
SFIT Abutment
K242287 · NHA
Dental · 410d
Cleared Dec 27, 2024
INNO SLA Mini Plus® Implant System
K241127 · DZE
Dental · 248d
Cleared Dec 20, 2023
INNO SLA Submerged Hybrid Ti-Base System
K231411 · NHA
Dental · 218d
Cleared Nov 21, 2023
Meta G UCLA Abutment
K232546 · NHA
Dental · 90d
Cleared Oct 18, 2023
INNO SLA Submerged Narrow Implant System
K231395 · DZE
Dental · 156d
Cleared Feb 24, 2023
InnoGenic Non-resorbable Membrane
K211554 · NPK
Dental · 646d
Cleared Jan 25, 2022
INNO SLA Submerged Implant System
K201323 · NHA
Dental · 617d
Cleared Dec 06, 2013
INNO SLA SUBMERGED IMPLANT SYSTEM
K132242 · DZE
Dental · 141d
Cleared Dec 20, 2010
COWELL IMPLANT SYSTEM
K100850 · DZE
Dental · 269d
Cleared Jul 29, 2009
ATLAS IMPLANT SYSTEM - WIDE PLUS
K090054 · DZE
Dental · 202d
Cleared Apr 20, 2009
ATLAS IMPLANT SYSTEM- MINI PLUS
K090049 · DZE
Dental · 103d
Cleared Feb 06, 2008
ATLAS IMPLANT SYSTEM
K071148 · DZE
Dental · 288d
Cleared Jul 28, 2005
ALLFIM IMPLANT SYSTEMS
K050635 · DZE
Dental · 119d
Cleared Sep 08, 2004
BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)
K041655 · DZE
Dental · 82d
Filters
Filter by Specialty
All14 Dental 14