Contour
Contour .018 UL/R 4/5 -7T 0A 0 0O
1manufacturer
27catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi TP Orthodontics Material Co., Ltd. | Wuxi | Jiangsu | Repacker / relabeller | 9 |
Record
| Listed by | Ortho Organizers, Inc., United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K110335 |
| Record published | 2016-09-24 |
| Record revised | 2025-12-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 303-01-5 | In distribution | |
| 303-04-5 | In distribution | |
| 303-10T-5 | In distribution | |
| 303-06-5 | In distribution | |
| 302-10-5 | In distribution | |
| 302-07-5 | In distribution | |
| 302-01-5 | In distribution | |
| 302-40C | In distribution | |
| 303-10-5 | In distribution | |
| 302-03-5 | In distribution | |
| 302-22C | In distribution | |
| 303-22C | In distribution | |
| 302-04-5 | In distribution | |
| 303-20C | In distribution | |
| 303-02-5 | In distribution | |
| 302-02-5 | In distribution | |
| 302-12-5 | In distribution | |
| 302-05-5 | In distribution | |
| 302-06-5 | In distribution | |
| 303-12-5 | In distribution | |
| 303-41C | In distribution | |
| 302-20C | In distribution | |
| 303-03-5 | In distribution | |
| 303-05-5 | In distribution | |
| 303-13-5 | In distribution | |
| 303-07-5 | In distribution | |
| 302-13-5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QuicKlear® | Forestadent Bernhard Förster GmbH | 841 |
| Bracket, Ceramic, Orthodontic | Flexmedics | 600 |
| Experience | GC Orthodontics America Inc. | 500 |
| TruKlear | Forestadent Bernhard Förster GmbH | 401 |
| Chic | GC Orthodontics America Inc. | 348 |
| Bracket, Ceramic, Orthodontic | Forestadent Bernhard Förster GmbH | 342 |
| IN-Ovation® C | Dentsply Sirona Orthodontics Inc. | 327 |
| Intrigue | Lancer Orthodontics, Inc. | 253 |
| Empower Clear | American Orthodontics | 250 |
| Empower Clear Bracket | American Orthodontics | 250 |
| InVu Ceramic Brackets | TP Orthodontics, Inc. | 226 |
| RadiancePlus | American Orthodontics | 179 |
Showing 12 of 399. All products under Bracket, Ceramic, Orthodontic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173440 | 2018-03-08 |
| K110335 | 2011-05-19 |
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.