TruKlear
The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single used…
The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single used only.
1manufacturer
401catalogue numbers in this listing
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 | Forestadent Bernhard Förster GmbH |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| 510(k) | K141104 |
| Record published | 2016-10-26 |
| Record revised | 2018-10-31 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Height 0.018 to 0.022 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| C706-2037 | Height.018 in | In distribution | |
| C715-1413 | Height.018 in | In distribution | |
| C706-2034 | Height.022 in | In distribution | |
| C713-0203-005 | 5 | In distribution | |
| C715-0201-010 | 10 | In distribution | |
| C714-1511-010 | 10 | In distribution | |
| C706-2032 | Height.022 in | In distribution | |
| C706-2001 | Height.018 in | In distribution | |
| C714-1203 | Height.018 in | In distribution | |
| C713-1613 | In distribution | ||
| C712-0511-005 | 5 | In distribution | |
| C714-1613 | In distribution | ||
| C712-0311 | In distribution | ||
| C715-0513 | Height.018 in | In distribution | |
| C712-0511 | In distribution | ||
| C706-2040 | In distribution | ||
| C715-0411 | In distribution | ||
| C706-2025 | Height.018 in | In distribution | |
| C715-0203-005 | 5 | In distribution | |
| C715-0513-010 | 10 | In distribution | |
| C713-1511-005 | 5 | In distribution | |
| C715-0203 | Height.018 in | In distribution | |
| C715-0401-005 | 5 | In distribution | |
| C706-2047 | Height.022 in | In distribution | |
| C712-0101-005 | 5 | In distribution | |
| C715-0401 | In distribution | ||
| C715-1613-010 | 10 | In distribution | |
| C706-2013 | Height.018 in | In distribution | |
| C714-0501 | In distribution | ||
| C714-0311 | Height.022 in | In distribution | |
| C715-1513-010 | 10 | In distribution | |
| C712-0311-005 | 5 | In distribution | |
| C714-0103-010 | 10 | In distribution | |
| C715-0501 | Height.022 in | In distribution | |
| C712-0513 | Height.018 in | In distribution | |
| C715-0403-005 | 5 | In distribution | |
| C715-0503-010 | 10 | In distribution | |
| C715-0513-005 | 5 | In distribution | |
| C713-0101 | In distribution | ||
| C715-0411-010 | 10 | In distribution | |
| C715-1611 | In distribution | ||
| C715-0403-010 | 10 | In distribution | |
| C706-2019 | In distribution | ||
| C706-2030 | Height.022 in | In distribution | |
| C715-1413 | In distribution | ||
| C706-2043 | Height.022 in | In distribution | |
| C714-1513 | Height.018 in | In distribution | |
| C712-0503-010 | 10 | In distribution | |
| C706-2007 | In distribution | ||
| C715-0413-005 | 5 | In distribution | |
| C714-0203-005 | 5 | In distribution | |
| C706-2008 | Height.022 in | In distribution | |
| C713-1611 | Height.022 in | In distribution | |
| C706-2014 | In distribution | ||
| C713-0503 | Height.018 in | In distribution | |
| C714-0313 | In distribution | ||
| C715-1611-010 | 10 | In distribution | |
| C706-2015 | In distribution | ||
| C715-0203-010 | 10 | In distribution | |
| C714-0403 | Height.018 in | In distribution | |
| C714-0411 | In distribution | ||
| C712-1513 | In distribution | ||
| C714-1611-010 | 10 | In distribution | |
| C714-0513-010 | 10 | In distribution | |
| C713-0511 | Height.022 in | In distribution | |
| C706-2018 | In distribution | ||
| C712-0201-005 | 5 | In distribution | |
| C712-0501 | Height.022 in | In distribution | |
| C715-0101-005 | 5 | In distribution | |
| C713-0503-010 | 10 | In distribution | |
| C714-0103-005 | 5 | In distribution | |
| C706-2044 | In distribution | ||
| C713-0313 | In distribution | ||
| C715-0103 | In distribution | ||
| C714-0201 | In distribution | ||
| C714-0401-005 | 5 | In distribution | |
| C715-1613 | In distribution | ||
| C712-1201-010 | 10 | In distribution | |
| C712-0313-005 | 5 | In distribution | |
| C713-0501-010 | 10 | In distribution | |
| C714-1201-005 | 5 | In distribution | |
| C715-1513-005 | 5 | In distribution | |
| C706-2041 | Height.018 in | In distribution | |
| C714-1203-005 | 5 | In distribution | |
| C713-1413-010 | 10 | In distribution | |
| C706-2031 | In distribution | ||
| C715-0401-010 | 10 | In distribution | |
| C714-0101-005 | 5 | In distribution | |
| C712-1511-005 | 5 | In distribution | |
| C714-0513 | In distribution | ||
| C714-1613-005 | 5 | In distribution | |
| C713-0501 | Height.022 in | In distribution | |
| C715-0103 | Height.018 in | In distribution | |
| C706-2000 | Height.018 in | In distribution | |
| C706-2046 | Height.022 in | In distribution | |
| C715-0313-005 | 5 | In distribution | |
| C706-2000 | In distribution | ||
| C715-0201 | In distribution | ||
| C713-0513 | In distribution | ||
| C714-0501-010 | 10 | In distribution | |
| C713-0103-010 | 10 | In distribution | |
| C713-1511 | Height.022 in | In distribution | |
| C706-2021 | In distribution | ||
| C715-0311 | In distribution | ||
| C715-1413-005 | 5 | In distribution | |
| C706-2038 | Height.018 in | In distribution | |
| C713-0201 | Height.022 in | In distribution | |
| C714-0401 | In distribution | ||
| C714-1201-010 | 10 | In distribution | |
| C706-2022 | Height.022 in | In distribution | |
| C713-0313-010 | 10 | In distribution | |
| C706-2026 | In distribution | ||
| C714-0401-010 | 10 | In distribution | |
| C713-0201-005 | 5 | In distribution | |
| C712-1611 | Height.022 in | In distribution | |
| C713-0503 | In distribution | ||
| C715-1513 | Height.018 in | In distribution | |
| C715-0313-010 | 10 | In distribution | |
| C706-2019 | Height.022 in | In distribution | |
| C706-2042 | In distribution | ||
| C706-2042 | Height.022 in | In distribution | |
| C715-0413 | Height.018 in | In distribution | |
| C713-0103-005 | 5 | In distribution | |
| C714-1611-005 | 5 | In distribution | |
| C712-0501-010 | 10 | In distribution | |
| C712-0203 | In distribution | ||
| C714-0313-010 | 10 | In distribution | |
| C712-0501-005 | 5 | In distribution | |
| C714-1203-010 | 10 | In distribution | |
| C714-1611 | In distribution | ||
| C712-0501 | In distribution | ||
| C714-0311-005 | 5 | In distribution | |
| C715-1511-005 | 5 | In distribution | |
| C713-0311 | Height.022 in | In distribution | |
| C706-2009 | In distribution | ||
| C714-1613 | Height.018 in | In distribution | |
| C715-0503-005 | 5 | In distribution | |
| C706-2018 | Height.022 in | In distribution | |
| C706-2005 | Height.018 in | In distribution | |
| C714-0413-010 | 10 | In distribution | |
| C714-0401 | Height.022 in | In distribution | |
| C712-1613 | In distribution | ||
| C706-2029 | In distribution | ||
| C706-2040 | Height.018 in | In distribution | |
| C714-0503 | In distribution | ||
| C706-2044 | Height.022 in | In distribution | |
| C714-0101 | In distribution | ||
| C712-1203 | Height.018 in | In distribution | |
| C706-2013 | In distribution | ||
| C715-0411-005 | 5 | In distribution | |
| C706-2031 | Height.022 in | In distribution | |
| C712-1611 | In distribution | ||
| C714-0403 | In distribution | ||
| C714-0313-005 | 5 | In distribution | |
| C715-0311 | Height.022 in | In distribution | |
| C706-2020 | In distribution | ||
| C715-0103-005 | 5 | In distribution | |
| C715-1513 | In distribution | ||
| C712-0311 | Height.022 in | In distribution | |
| C714-0411 | Height.022 in | In distribution | |
| C713-1613-010 | 10 | In distribution | |
| C706-2012 | In distribution | ||
| C706-2010 | In distribution | ||
| C706-2002 | In distribution | ||
| C706-2032 | In distribution | ||
| C712-1201-005 | 5 | In distribution | |
| C712-0103 | Height.018 in | In distribution | |
| C714-0503-005 | 5 | In distribution | |
| C712-1511 | Height.022 in | In distribution | |
| C714-0313 | Height.018 in | In distribution | |
| C714-0501 | Height.022 in | In distribution | |
| C712-1613 | Height.018 in | In distribution | |
| C713-0311 | In distribution | ||
| C713-0203 | In distribution | ||
| C712-0503 | Height.018 in | In distribution | |
| C713-1513-010 | 10 | In distribution | |
| C707-3015 | In distribution | ||
| C712-1513 | Height.018 in | In distribution | |
| C715-0101-010 | 10 | In distribution | |
| C714-0101-010 | 10 | In distribution | |
| C715-0313 | In distribution | ||
| C714-0311 | In distribution | ||
| C712-0513 | In distribution | ||
| C712-1611-010 | 10 | In distribution | |
| C713-0311-005 | 5 | In distribution | |
| C713-0203-010 | 10 | In distribution | |
| C715-0413-010 | 10 | In distribution | |
| C714-0101 | Height.022 in | In distribution | |
| C706-2004 | In distribution | ||
| C712-0311-010 | 10 | In distribution | |
| C712-0103-005 | 5 | In distribution | |
| C713-1413 | In distribution | ||
| C712-1413 | In distribution | ||
| C713-0203 | Height.018 in | In distribution | |
| C712-1413-010 | 10 | In distribution | |
| C714-1613-010 | 10 | In distribution | |
| C712-1511-010 | 10 | In distribution | |
| C715-0501-010 | 10 | In distribution | |
| C714-1413-005 | 5 | In distribution | |
| C714-0201-010 | 10 | In distribution | |
| C713-0311-010 | 10 | In distribution | |
| C714-1413 | In distribution | ||
| C715-0511-010 | 10 | In distribution | |
| C714-0203 | Height.018 in | In distribution | |
| C714-1411-005 | 5 | In distribution | |
| C715-1411-010 | 10 | In distribution | |
| C712-1411-010 | 10 | In distribution | |
| C712-1611-005 | 5 | In distribution | |
| C712-1201 | In distribution | ||
| C714-1201 | Height.022 in | In distribution | |
| C706-2005 | In distribution | ||
| C706-2036 | Height.018 in | In distribution | |
| C715-0413 | In distribution | ||
| C706-2025 | In distribution | ||
| C712-0503 | In distribution | ||
| C706-2045 | Height.022 in | In distribution | |
| C712-1203 | In distribution | ||
| C715-1411 | Height.022 in | In distribution | |
| C714-1411-010 | 10 | In distribution | |
| C706-2011 | Height.022 in | In distribution | |
| C712-0513-005 | 5 | In distribution | |
| C714-0413-005 | 5 | In distribution | |
| C712-0201 | In distribution | ||
| C706-2030 | In distribution | ||
| C706-2015 | Height.018 in | In distribution | |
| C715-0311-010 | 10 | In distribution | |
| C713-0513-005 | 5 | In distribution | |
| C706-2020 | Height.022 in | In distribution | |
| C706-2021 | Height.022 in | In distribution | |
| C706-2006 | In distribution | ||
| C715-0101 | In distribution | ||
| C712-1411 | In distribution | ||
| C714-0511-010 | 10 | In distribution | |
| C712-0511-010 | 10 | In distribution | |
| C712-1413 | Height.018 in | In distribution | |
| C715-0403 | In distribution | ||
| C713-0313 | Height.018 in | In distribution | |
| C712-1513-010 | 10 | In distribution | |
| C715-1511 | Height.022 in | In distribution | |
| C713-0513 | Height.018 in | In distribution | |
| C714-0513-005 | 5 | In distribution | |
| C706-2017 | In distribution | ||
| C715-0311-005 | 5 | In distribution | |
| C714-0413 | Height.018 in | In distribution | |
| C715-1413-010 | 10 | In distribution | |
| C706-2043 | In distribution | ||
| C712-0203 | Height.018 in | In distribution | |
| C706-2035 | Height.022 in | In distribution | |
| C713-1613-005 | 5 | In distribution | |
| C712-1613-010 | 10 | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| InVu Readi-Base Brackets | TP Orthodontics, Inc. | 173 |
Showing 12 of 399. All products under Bracket, Ceramic, Orthodontic
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.