Manufacturer registered with FDA

ASO International Manila, Inc.

Cavite,Region IVa,, Philippines. Lists 8 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10056058Manufacturer
Device types listed
8
Brands and models
5
510(k) clearances
12021–2021
Markets registered in
1United States
Establishments
1Philippines
2021: 120102020

510(k) clearances per year, 2007–2026

Devices listed with FDA

What ASO International Manila, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Orthodontic Screw Expansion RetainerDYJ · Class 1Retainers, expanders & headgearMaker—2021
Orthodontic TubeDZD · Class 1Orthodontic wires & bandsMaker
Double Tube (DT)Tube for Forsus
2017
Orthodontic Preformed BandECM · Class 1Orthodontic wires & bandsMaker
Customized Bands
2017
Orthodontic Wire ClampECN · Class 1—Maker
Harmony
2017
Orthodontic Metal BracketEJF · Class 1Orthodontic bracketsMaker
Harmony H32
2017
Preformed Tooth PositionerKMY · Class 1Retainers, expanders & headgearMaker—2021
Sequential AlignerNXC · Class 2Clear alignersMaker—2021
Indirect Bonding TrayQJJ · Class 1—Maker—2021

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names ASO International Manila, Inc. as the applicant.

Decided510(k)DeviceDevice type
26 Feb 2021K201104AsoAlignerNXC Sequential Aligner

Registered establishments

EstablishmentLocationWhat it does
ASO INTERNATIONAL MANILA, INC.FDA reg. 3014054179Cavite,Region IVa,, PhilippinesManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10056058). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.