Bracket, Ceramic, Orthodontic
Metal Lined Cermic Twin ROTH .018 HK/345 METAL-LINED CERAMIC W/CASE
1manufacturer
600catalogue 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 | Flexmedics, United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| 510(k) | K132368 |
| Record published | 2020-05-26 |
| Record revised | 2023-07-26 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 125-U4-2RK-V | 5 | In distribution | |
| KTRCR1955A | In distribution | ||
| 60-L4-8RK-V | 5 | In distribution | |
| EDCRU218A-V | 5 | In distribution | |
| RCRLL323A-V | 5 | In distribution | |
| 50-U3-2RK-V | 5 | In distribution | |
| 76-L3-8RK0-V | 5 | In distribution | |
| 55K-345-18-01 | In distribution | ||
| 55-L1-8U-V | 5 | In distribution | |
| 57-U4-8UK-V | 5 | In distribution | |
| 57-U1-2L-V | 5 | In distribution | |
| 75-L5-2LK-V | 5 | In distribution | |
| 62K-EDGE-18-01 | In distribution | ||
| 75K-3-22-01 | In distribution | ||
| 76-U4-8RK-V | 5 | In distribution | |
| 56K-3-18-01 | In distribution | ||
| 75-U4-8U-V | 5 | In distribution | |
| 52-ANT-18-V | 5 | In distribution | |
| 55-U1-8R-V | 5 | In distribution | |
| 56-L5-2U-V | 5 | In distribution | |
| 50-L4-8U-V | 5 | In distribution | |
| 60-L5-8U-V | 5 | In distribution | |
| 51K-345-22-01 | In distribution | ||
| 57-L4-2L-V | 5 | In distribution | |
| 55-U4-2UK-V | 5 | In distribution | |
| 51-U2-2R-V | 5 | In distribution | |
| 125-U2-2R-V | 5 | In distribution | |
| EDCRU222A-V | 5 | In distribution | |
| 51-L4-2R-V | 5 | In distribution | |
| 55-U4-8UK-V | 5 | In distribution | |
| 50-L3-2L-V | 5 | In distribution | |
| 126-U1-2L-V | 5 | In distribution | |
| 51-L5-2RK-V | 5 | In distribution | |
| 55-U4-8U-V | 5 | In distribution | |
| 57-U2-2R-V | 5 | In distribution | |
| 57-U3-8LK-V | 5 | In distribution | |
| KTRCR1855A | In distribution | ||
| 57-L3-2LK-V | 5 | In distribution | |
| VCRUR222-V | 5 | In distribution | |
| 51-L3-8RK-V | 5 | In distribution | |
| 55-U3-8RK-V | 5 | In distribution | |
| 57-L3-8L-V | 5 | In distribution | |
| 61-U3-2RK-V | 5 | In distribution | |
| 126-L1-2U-V | 5 | In distribution | |
| 61-L5-2U-V | 5 | In distribution | |
| 60-L4-2RK-V | 5 | In distribution | |
| 75K-3-22-6 | In distribution | ||
| 76-U3-8LK0-V | 5 | In distribution | |
| 60-L3-2L-V | 5 | In distribution | |
| 51-U1-2L-V | 5 | In distribution | |
| 75K-345-18-01 | In distribution | ||
| 125-U2-8R-V | 5 | In distribution | |
| KTRCR2355A | In distribution | ||
| 50K-345-18-01 | In distribution | ||
| 125-L5-2LK-V | 5 | In distribution | |
| 56-U3-8RK-V | 5 | In distribution | |
| 60-U2-2R-V | 5 | In distribution | |
| 55-U1-2R-V | 5 | In distribution | |
| 55-U2-8L-V | 5 | In distribution | |
| 61-L5-8LK-V | 5 | In distribution | |
| 60-U3-2RK-V | 5 | In distribution | |
| 60-L3-8LK-V | 5 | In distribution | |
| 61-U4-8U-V | 5 | In distribution | |
| 51-U1-8L-V | 5 | In distribution | |
| 61K-345-18-01 | In distribution | ||
| 51-L4-8LK-V | 5 | In distribution | |
| 60-U3-8LK-V | 5 | In distribution | |
| 75K-345-22-10 | In distribution | ||
| 125-U1-2L-V | 5 | In distribution | |
| 51K-345-18-01 | In distribution | ||
| KTEDCR2255A | In distribution | ||
| 57-L1-8U-V | 5 | In distribution | |
| 76-L5-8U-V | 5 | In distribution | |
| 57-L3-8RK-V | 5 | In distribution | |
| 60K-NHK-18-01 | In distribution | ||
| 51-L4-8L-V | 5 | In distribution | |
| 55-L5-8UK-V | 5 | In distribution | |
| 50-L5-8U-V | 5 | In distribution | |
| VCRUL323-V | 5 | In distribution | |
| 55K-NHK-18-01 | In distribution | ||
| 50-L4-2UK-V | 5 | In distribution | |
| 55K-345-22-01 | In distribution | ||
| 126-L4-2LK-V | 5 | In distribution | |
| 51-U3-8L-V | 5 | In distribution | |
| 57-U2-2L-V | 5 | In distribution | |
| 75-L3-2LK-V | 5 | In distribution | |
| 57K-345-18-01 | In distribution | ||
| 60-L1-8U-V | 5 | In distribution | |
| 51K-3-18-01 | In distribution | ||
| 51-L4-2LK-V | 5 | In distribution | |
| 57-U2-8L-V | 5 | In distribution | |
| 125-L4-8RK-V | 5 | In distribution | |
| 75-L5-8LK-V | 5 | In distribution | |
| 56-U1-8L-V | 5 | In distribution | |
| 61-L3-2LK-V | 5 | In distribution | |
| 75-L1-8U-V | 5 | In distribution | |
| EDCRU418A-V | 5 | In distribution | |
| RCRLR319A-V | 5 | In distribution | |
| 57-L4-8LK-V | 5 | In distribution | |
| 56-L4-2UK-V | 5 | In distribution | |
| RCRUR118A-V | 5 | In distribution | |
| 125-U1-8R-V | 5 | In distribution | |
| 76-L3-2LK-V | 5 | In distribution | |
| 126-L5-2LK-V | 5 | In distribution | |
| 61-L5-8U-V | 5 | In distribution | |
| 60-U4-2RK-V | 5 | In distribution | |
| 50K-3-18-01 | In distribution | ||
| 60-U4-8LK-V | 5 | In distribution | |
| 76K-345-18-05 | In distribution | ||
| 75-L4-2RK-V | 5 | In distribution | |
| 61-U2-8R-V | 5 | In distribution | |
| 60-U2-2L-V | 5 | In distribution | |
| 63K-3-18-01 | In distribution | ||
| 61K-NHK-18-01 | In distribution | ||
| KTECR185533A | In distribution | ||
| 76-L4-8RK-V | 5 | In distribution | |
| 75-U3-2RK-V | 5 | In distribution | |
| 61-L3-2R-V | 5 | In distribution | |
| KTRCR2255A | In distribution | ||
| 55-U2-8R-V | 5 | In distribution | |
| 76K-345-22-05 | In distribution | ||
| 57-L5-2RK-V | 5 | In distribution | |
| 56-U1-2R-V | 5 | In distribution | |
| 76-U4-2U-V | 5 | In distribution | |
| 61-L4-8RK-V | 5 | In distribution | |
| 52-LAT-18-V | 5 | In distribution | |
| 51-L5-8RK-V | 5 | In distribution | |
| 56-L4-8UK-V | 5 | In distribution | |
| 76-U2-8L-V | 5 | In distribution | |
| 50-L3-8LK-V | 5 | In distribution | |
| 75K-3-18-05 | In distribution | ||
| 57-L4-8L-V | 5 | In distribution | |
| 61-L5-2RK-V | 5 | In distribution | |
| 126-L5-8LK-V | 5 | In distribution | |
| 60-U2-8L-V | 5 | In distribution | |
| 56-U4-2U-V | 5 | In distribution | |
| 50-L3-2RK-V | 5 | In distribution | |
| 51-L3-2LK-V | 5 | In distribution | |
| 76-U3-8LK-V | 5 | In distribution | |
| 126-U3-8RK-V | 5 | In distribution | |
| 125-U3-2RK-V | 5 | In distribution | |
| 75-U1-2L-V | 5 | In distribution | |
| 75-U2-2L-V | 5 | In distribution | |
| 56-L3-8RK-V | 5 | In distribution | |
| RCRUU419A-V | 5 | In distribution | |
| 76-U4-2RK-V | 5 | In distribution | |
| 51-U1-8R-V | 5 | In distribution | |
| 75-L4-8U-V | 5 | In distribution | |
| 56-L3-2RK-V | 5 | In distribution | |
| 126-U3-2LK-V | 5 | In distribution | |
| 126-U1-2R-V | 5 | In distribution | |
| 56-U3-2R-V | 5 | In distribution | |
| 57-U1-8R-V | 5 | In distribution | |
| 61-L1-8U-V | 5 | In distribution | |
| 126-L4-2RK-V | 5 | In distribution | |
| 61-U3-8R-V | 5 | In distribution | |
| 76-U1-2R-V | 5 | In distribution | |
| 55K-3-18-01 | In distribution | ||
| 55-U3-2L-V | 5 | In distribution | |
| 60-U2-8R-V | 5 | In distribution | |
| 51-U2-8R-V | 5 | In distribution | |
| 61K-345-22-01 | In distribution | ||
| 61-U3-8RK-V | 5 | In distribution | |
| 55-U3-8L-V | 5 | In distribution | |
| 76-L3-8LK0-V | 5 | In distribution | |
| 57-L5-8R-V | 5 | In distribution | |
| 57-L5-2R-V | 5 | In distribution | |
| 51-L5-2R-V | 5 | In distribution | |
| 57-U4-2U-V | 5 | In distribution | |
| 75-U4-8LK-V | 5 | In distribution | |
| 75-U1-8L-V | 5 | In distribution | |
| 55-L3-2L-V | 5 | In distribution | |
| 76-L5-2U-V | 5 | In distribution | |
| 125-L4-2LK-V | 5 | In distribution | |
| 60-L3-8RK-V | 5 | In distribution | |
| 126K-345-18-01 | In distribution | ||
| 126-U2-2L-V | 5 | In distribution | |
| 60-U4-2U-V | 5 | In distribution | |
| 55-L3-8RK-V | 5 | In distribution | |
| 126-L5-2RK-V | 5 | In distribution | |
| 55-U2-2R-V | 5 | In distribution | |
| 126-U2-8L-V | 5 | In distribution | |
| 125-L3-8LK-V | 5 | In distribution | |
| 58K-EDGE-18-01 | In distribution | ||
| 75-U1-2R-V | 5 | In distribution | |
| 50K-345-22-01 | In distribution | ||
| 57K-3-22-01 | In distribution | ||
| 55-L4-8UK-V | 5 | In distribution | |
| 76-U3-2RK-V | 5 | In distribution | |
| 50-L5-2U-V | 5 | In distribution | |
| 52-CUSP-22-V | 5 | In distribution | |
| RCRLU423A-V | 5 | In distribution | |
| 75-L4-8LK-V | 5 | In distribution | |
| 76-U3-8RK-V | 5 | In distribution | |
| RCRUR218A-V | 5 | In distribution | |
| 125-U1-8L-V | 5 | In distribution | |
| 61-U4-2LK-V | 5 | In distribution | |
| 75-U2-8R-V | 5 | In distribution | |
| 125-U4-8LK-V | 5 | In distribution | |
| 57-L3-8LK-V | 5 | In distribution | |
| 50K-3-22-01 | In distribution | ||
| 60-U3-8RK-V | 5 | In distribution | |
| 76-L4-2RK-V | 5 | In distribution | |
| 57-L5-8L-V | 5 | In distribution | |
| 50-U1-8L-V | 5 | In distribution | |
| 61-U4-2RK-V | 5 | In distribution | |
| 60-L3-8L-V | 5 | In distribution | |
| 60-U4-8RK-V | 5 | In distribution | |
| 76-U3-2LK0-V | 5 | In distribution | |
| 55-U1-2L-V | 5 | In distribution | |
| 56-L3-2L-V | 5 | In distribution | |
| 50-L1-8U-V | 5 | In distribution | |
| 51-L3-2L-V | 5 | In distribution | |
| 55-U3-2LK-V | 5 | In distribution | |
| 57-U3-8R-V | 5 | In distribution | |
| 76K-3-22-05 | In distribution | ||
| 56-U3-8R-V | 5 | In distribution | |
| 76-L4-8U-V | 5 | In distribution | |
| 50-U2-8R-V | 5 | In distribution | |
| 126-U4-2LK-V | 5 | In distribution | |
| 76-U4-8U-V | 5 | In distribution | |
| VCRLR323-V | 5 | In distribution | |
| 75-U4-8RK-V | 5 | In distribution | |
| 126-L1-8U-V | 5 | In distribution | |
| 61-U2-2L-V | 5 | In distribution | |
| RCRL422A-V | 5 | In distribution | |
| 51-U2-2L-V | 5 | In distribution | |
| 55-L4-8U-V | 5 | In distribution | |
| 62-ANT-22-V | 5 | In distribution | |
| RCRLR118A-V | 5 | In distribution | |
| 51-L3-2RK-V | 5 | In distribution | |
| 55-U4-2U-V | 5 | In distribution | |
| 56-U2-2R-V | 5 | In distribution | |
| 60-L5-2RK-V | 5 | In distribution | |
| 52K-EDGE-22-01 | In distribution | ||
| 125-L3-2LK-V | 5 | In distribution | |
| 51-U3-2R-V | 5 | In distribution | |
| 61-U2-8L-V | 5 | In distribution | |
| 51-L3-2R-V | 5 | In distribution | |
| 57-L4-2RK-V | 5 | In distribution | |
| 50-U4-2UK-V | 5 | In distribution | |
| 51-L5-8LK-V | 5 | In distribution | |
| 75K-345-22-01 | In distribution | ||
| 51-L5-8R-V | 5 | In distribution | |
| 51-U1-2R-V | 5 | In distribution | |
| 56-L3-8R-V | 5 | In distribution | |
| RCRUU423A-V | 5 | In distribution | |
| 75-U3-2LK-V | 5 | In distribution | |
| 61-L3-8RK-V | 5 | In distribution | |
| RCRLR122A-V | 5 | In distribution |
Showing 250 of 300 catalogue numbers.
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| 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 |
| 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.