FDA.reportPublic FDA data

510(k) K201104

Device
AsoAligner
Applicant
Aso International Manila, Inc.
510(k) number
K201104
Product code
NXC  
Decision
Substantially Equivalent (SESE)
Decision date
2021-02-26
Date received
2020-04-24
Regulation
872.5470
Classification name
Aligner, Sequential
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Hiromichi Takahashi
Address
Atlantica Bldg. 5, Block 12, Phase 1, S. Ave., Cavite Economic Zone Cavite PH 4106 4106

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NXC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260788Smylio AlignersSmylio, Inc.2026-05-08
K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.2026-04-15
K253282ZSmile SystemDror Orthodesign , Ltd.2026-02-03
K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) Limited2026-01-07
K250739Primeprint Direct AlignerDreve Dentamid GmbH2025-11-07
K252931Invisalign® Palatal Expander SystemAlign Technology, Inc.2025-10-23
K252870Invisalign Specifix Attachment SystemAlign Technology, Inc.2025-10-09
K251758Serafin®Tns Co., Ltd.2025-09-11
K252380Invisalign SystemAlign Technology, Inc.2025-08-29
K251415Additively Manufactured Aligner ResinAidite (Qinhuangdao) Technology Co., Ltd.2025-08-27
K251616Clear MiracleOds Co., Ltd.2025-07-22
K242637MEM Clear Aligner SystemMem Dental Technology Co., Ltd.2025-05-21
K250343LuxCreo Clear Aligner SystemLuxCreo, Inc.2025-04-08
K250487SparkTM Clear Aligner SystemOrmco Corporation2025-02-20
K242715Pearl Clear AlignerPearl Digital, Inc.2025-01-16

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases