Data / Medical devices / Philippines / Aso International Manila, Inc.
Aso International Manila, Inc.: FDA-registered device maker in Cavite,Region IVa,, Philippines, 1 510(k) clearance
Aso International Manila, Inc. is registered with the FDA (registration 3014054179) in Cavite,Region IVa,, Philippines. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 26, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014054179
- Address
- Atlantica Building 5, Block 12, Phase 1, South Avenue Cavite Economic Zone, Rosario, Cavite,Region IVa,, Philippines, 4106
- Owner or operator
- ASO International Manila, Inc. (10056058)
- Roles
- Manufacturer
- First device listed
- October 31, 2017
- Registered through
- 2027
- Brand names listed
- Customized Bands, Double Tube (DT), Harmony, Harmony H32, Tube for Forsus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Manufacturer | accessdata.fda.gov |
| Band, Preformed, Orthodontic | ECM | 1 | Manufacturer | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Manufacturer | accessdata.fda.gov |
| Clamp, Wire, Orthodontic | ECN | 1 | Manufacturer | accessdata.fda.gov |
| Indirect Bonding Tray | QJJ | 1 | Manufacturer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Manufacturer | accessdata.fda.gov |
| Retainer, Screw Expansion, Orthodontic | DYJ | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 26, 2021 | K201104 | AsoAligner | NXC | Substantially Equivalent | Aso International Manila, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Band, Preformed, Orthodontic
- All makers of Indirect Bonding Tray
- All makers of Tube, Orthodontic
- All makers of Clamp, Wire, Orthodontic
- All makers of Positioner, Tooth, Preformed
- All makers of Bracket, Metal, Orthodontic
Updated February 26, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.