Manufacturer registered with FDA
Astar Orthodontics Inc
SHANGHAI, China. Lists 12 dental device types with FDA across 1 registered establishment.
- Device types listed
- 12
- Brands and models
- 28
- 510(k) clearances
- 0as applicant
- Markets registered in
- 792 registrations outside the US
- Establishments
- 1China
Registered in 7 markets
Where regulators' registries name Astar Orthodontics Inc as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Astar Orthodontics Inc | 12 device types | — | Below |
| European Union | EUDAMED | Manufacturer | ASTAR ORTHODONTICS INC. | 59 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Astar Orthodontics Inc. | 13 | 2024–2024 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Astar Orthodontics Inc. | 8 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ASTAR ORTHODONTICS INC.ASTAR ORTHODONTICS INC | 6 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Astar Orthodontics Inc | 3 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Astar Orthodontics Inc. | 3 | 2016–2016 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Astar Orthodontics Inc currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Maker | band | 2004 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Ligature wireNiti wireStainless Steel wire | 2007 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | Mico¿ tubes | 2004 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | stailess steel photo mirrors, double polished,setstainless steel photo mirror, oclussionalstainless steel photo mirrors, buccalstainless steel photo mirrors, lingualstainless steel photo mirrors, single polished, set | 2007 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | ligature elastic, cat shapeligature elastic, flower shapeligature elastic, mouse shape | 2004 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | Guchi bandsKola bandPremolar Band1st Molar Band2nd Molar bands | 2007 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | Niti Spring, CloseNiti Spring, Open | 2007 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | check retractor, bigcheck retractor, mediumcheck retractor, small | 2008 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | — | 2004 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | lingual retainer, lowerlingual retainer, upper | 2007 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | ligature cutter, bird beak pliers, Omega loop forming pliers, Tweed loop forming pliers, turret, End cutter | 2007 |
| FacebowKCR · Class 1 | Articulators & facebows | Maker | facebow w/loopsfacebow, universal | 2008 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ASTAR ORTHODONTICS INC.FDA reg. 3004704962 | SHANGHAI, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9065482). 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.