Henry Schein
Ceraket .022 UR 4/5 HK -7T/0A 0Off Roth
1manufacturer
97catalogue 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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Record published | 2019-11-11 |
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 |
|---|---|---|---|
| 1125929 | 5 | In distribution | |
| 1125877 | 5 | In distribution | |
| 1125938 | 5 | In distribution | |
| 1125932 | 5 | In distribution | |
| 1125944 | 5 | In distribution | |
| 1125908 | 5 | In distribution | |
| 1125879 | 5 | In distribution | |
| 1125856 | 5 | In distribution | |
| 1125875 | 5 | In distribution | |
| 1125916 | 5 | In distribution | |
| 1125928 | 5 | In distribution | |
| 1125910 | 5 | In distribution | |
| 1125886 | 5 | In distribution | |
| 1125902 | 20 | In distribution | |
| 1125851 | 5 | In distribution | |
| 1125888 | 5 | In distribution | |
| 1125895 | 5 | In distribution | |
| 1125891 | 5 | In distribution | |
| 1125935 | 5 | In distribution | |
| 1125954 | 5 | In distribution | |
| 1125883 | 5 | In distribution | |
| 1125846 | 5 | In distribution | |
| 1125850 | 5 | In distribution | |
| 1125878 | 5 | In distribution | |
| 1125859 | 5 | In distribution | |
| 1125903 | 5 | In distribution | |
| 1125945 | 5 | In distribution | |
| 1125852 | 5 | In distribution | |
| 1125913 | 5 | In distribution | |
| 1125845 | 5 | In distribution | |
| 1125847 | 5 | In distribution | |
| 1125858 | 5 | In distribution | |
| 1125863 | 5 | In distribution | |
| 1125937 | 5 | In distribution | |
| 1125848 | 5 | In distribution | |
| 1125869 | 5 | In distribution | |
| 1125898 | 20 | In distribution | |
| 1125940 | 5 | In distribution | |
| 1125915 | 5 | In distribution | |
| 1125917 | 5 | In distribution | |
| 1125870 | 5 | In distribution | |
| 1125894 | 5 | In distribution | |
| 1125907 | 5 | In distribution | |
| 1125876 | 5 | In distribution | |
| 1125946 | 5 | In distribution | |
| 1125955 | 5 | In distribution | |
| 1125897 | 5 | In distribution | |
| 1125956 | 5 | In distribution | |
| 1125959 | 20 | In distribution | |
| 1125931 | 5 | In distribution | |
| 1125904 | 5 | In distribution | |
| 1125959 | 20 | In distribution | |
| 1125919 | 5 | In distribution | |
| 1125880 | 5 | In distribution | |
| 1125923 | 5 | In distribution | |
| 1125865 | 5 | In distribution | |
| 1125952 | 5 | In distribution | |
| 1125914 | 5 | In distribution | |
| 1125948 | 5 | In distribution | |
| 1125896 | 5 | In distribution | |
| 1125909 | 5 | In distribution | |
| 1125960 | 20 | In distribution | |
| 1125849 | 5 | In distribution | |
| 1125921 | 5 | In distribution | |
| 1125866 | 5 | In distribution | |
| 1125874 | 5 | In distribution | |
| 1125927 | 5 | In distribution | |
| 1125922 | 5 | In distribution | |
| 1125949 | 5 | In distribution | |
| 1125934 | 5 | In distribution | |
| 1125958 | 5 | In distribution | |
| 1125859 | 5 | In distribution | |
| 1125861 | 5 | In distribution | |
| 1125906 | 5 | In distribution | |
| 1125860 | 5 | In distribution | |
| 1125900 | 20 | In distribution | |
| 1125853 | 5 | In distribution | |
| 1125912 | 5 | In distribution | |
| 1125947 | 5 | In distribution | |
| 1125871 | 5 | In distribution | |
| 1125889 | 5 | In distribution | |
| 1125873 | 5 | In distribution | |
| 1125930 | 5 | In distribution | |
| 1125936 | 5 | In distribution | |
| 1125933 | 5 | In distribution | |
| 1125941 | 5 | In distribution | |
| 1125890 | 5 | In distribution | |
| 1125918 | 5 | In distribution | |
| 1125957 | 5 | In distribution | |
| 1125905 | 5 | In distribution | |
| 1125887 | 5 | In distribution | |
| 1125924 | 5 | In distribution | |
| 1125862 | 5 | In distribution | |
| 1125857 | 5 | In distribution | |
| 1125881 | 5 | In distribution | |
| 1125864 | 5 | In distribution | |
| 1125882 | 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
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.