Damon Clear
Single Patient KIT UP5-5HK / LO3-3
1manufacturer
31catalogue numbers in this listing
3510(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 | Ormco Corporation, United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-08 |
| Record revised | 2018-03-29 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 497-7480 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6490 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6474 | Slot Width:.022 Inch | 10 | In distribution |
| 497-7484 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6475 | Slot Width:.022 Inch | 10 | In distribution |
| 497-7490 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6430 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6467 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6480 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6411 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6481 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6461 | Slot Width:.022 Inch | 10 | In distribution |
| 740-1301 | Slot Width:.022 Inch | In distribution | |
| 497-6471 | Slot Width:.022 Inch | 10 | In distribution |
| 497-7483 | Slot Width:.022 Inch | 10 | In distribution |
| 497-7481 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6410 | Slot Width:.022 Inch | 10 | In distribution |
| 497-7491 | Slot Width:.022 Inch | 10 | In distribution |
| 497-7485 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6491 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6470 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6472 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6460 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6462 | Slot Width:.022 Inch | 10 | In distribution |
| 497-7482 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6421 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6463 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6431 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6473 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6420 | Slot Width:.022 Inch | 10 | In distribution |
| 497-6466 | Slot Width:.022 Inch | 10 | 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 |
|---|---|
| K172845 | 2018-01-31 |
| K171844 | 2017-07-18 |
| K081415 | 2008-09-24 |
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.