Nexus Clear Roth
U4/5L.022 -7/0/-2 HK
1manufacturer
24catalogue 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 | 2023-10-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2023-10-25 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 436-3111 | Slot Width:.018 Inch | 10 | Withdrawn |
| 437-4511 | Slot Width:.022 Inch | 10 | Withdrawn |
| 436-3110 | Slot Width:.018 Inch | 10 | Withdrawn |
| 436-4511 | Slot Width:.018 Inch | 10 | Withdrawn |
| 436-4710 | Slot Width:.018 Inch | 10 | Withdrawn |
| 437-4711 | Slot Width:.022 Inch | 10 | Withdrawn |
| 436-3210 | Slot Width:.018 Inch | 10 | Withdrawn |
| 437-3610 | Slot Width:.022 Inch | 10 | Withdrawn |
| 436-4311 | Slot Width:.018 Inch | 10 | Withdrawn |
| 437-3111 | Slot Width:.022 Inch | 10 | Withdrawn |
| 437-3611 | Slot Width:.022 Inch | 10 | Withdrawn |
| 437-4710 | Slot Width:.022 Inch | 10 | Withdrawn |
| 437-4310 | Slot Width:.022 Inch | 10 | Withdrawn |
| 437-4311 | Slot Width:.022 Inch | 10 | Withdrawn |
| 436-3610 | Slot Width:.018 Inch | 10 | Withdrawn |
| 436-3611 | Slot Width:.018 Inch | 10 | Withdrawn |
| 436-3211 | Slot Width:.018 Inch | 10 | Withdrawn |
| 437-3211 | Slot Width:.022 Inch | 10 | Withdrawn |
| 437-4510 | Slot Width:.022 Inch | 10 | Withdrawn |
| 437-3210 | Slot Width:.022 Inch | 10 | Withdrawn |
| 436-4711 | Slot Width:.018 Inch | 10 | Withdrawn |
| 436-4510 | Slot Width:.018 Inch | 10 | Withdrawn |
| 436-4310 | Slot Width:.018 Inch | 10 | Withdrawn |
| 437-3110 | Slot Width:.022 Inch | 10 | Withdrawn |
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.