Wuxi TP Orthodontics Material Co., Ltd.
Registered establishment in Wuxi, Jiangsu, China. 9 device types.
Wuxi TP Orthodontics Material Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Wire, Orthodontic, Strip, Polishing Agent and 7 other device types. Its earliest product listing with the FDA dates from 2006.
Registration
| Registered name | WUXI TP ORTHODONTICS MATERIAL CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005537733 |
| FEI number | 3005537733 |
| Establishment type | Repacker / relabeller, Manufacturer |
Location
| City | Wuxi |
|---|---|
| Province | Jiangsu |
| Address | L2, A2 BUILDING, LIYUAN ECONOMIC DEVELOPMENT ZONE |
| Postal code | 214072 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Band, Elastic, Orthodontic | Class 1 | Elastomeric tubing, E-Chain, Super Slick, Sep-A-Rings, TPO Latex Elastics, TPO Elastic thread and 9 more | 2006 | 36 |
| Band, Preformed, Orthodontic | Class 1 | PRE-FIT Preformed Bands, Molar Band Assemblies, Molar Band | 2006 | 27 |
| Bracket, Ceramic, Orthodontic | Class 2 | InVu, ClearVu, MXI, Plus Ceramic, Tip Edge PLUS with pre-applied adhesive, ClearVu with pre-applied adhesive and 1 more | 2008 | 1 |
| Bracket, Metal, Orthodontic | Class 1 | Generations Brackets, Begg Metal Bracket, Nu-Edge NX, Tip-Edge Plus Metal, Nu-Edge II Cobalt Chromium Twin bracket, Tip-Edge Plus NX and 5 more | 2006 | 52 |
| Clamp, Wire, Orthodontic | Class 1 | Crimpable Hook, Crimpable Stops, Retaining Rings, Lingual Cleat attachments, Separation Maintainers, Lingual Hook attachments and 10 more | 2006 | 27 |
| Instrument, Ligature Tucking, Orthodontic | Class 1 | Straight shooter Ligature Applicator | 2014 | 10 |
| Positioner, Tooth, Preformed | Class 1 | Pre-Finisher, Custom retainer, Custom tooth positioner, Pre-finisher appliance with seating spring | 2008 | 19 |
| Strip, Polishing Agent | Class 1 | Mesio-Distal Reducer | 2006 | 18 |
| Wire, Orthodontic | Class 1 | Lip Bumper with Pads, Preformed Ligature Ties, Aesthetic Stainless Steel Preformed Archwire, Multi-Strand Preformed Archwire, Stainless Steel Straight Archwire, Ligature Wire on Spool and 14 more | 2006 | 43 |
Clearances
No clearance names Wuxi TP Orthodontics Material Co., Ltd. as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K950992 | 1995-05-03 | NJM | Traditional | TP Orthodontics, Inc. |
| K780619 | 1978-06-28 | KMY | Traditional | Tp Laboratories, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1942 |
|---|---|
| Employees | 501-1000 |
| Main products | Bracket systems, Molar bands and tubes, Class II correction appliances, Custom lab services, Archwire |
| Export markets | over 50 countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.