Diamante™ MBT Ceramic Brackets
DIAMANTE™ MBT .018 LL5 HK -17°T +2°A Diamante™ ceramic brackets are transparent and nearly invisible as they composed of 99.9% pure polycrystalline alumina. They are impervious to stains…
DIAMANTE™ MBT.018 LL5 HK -17°T +2°A Diamante™ ceramic brackets are transparent and nearly invisible as they composed of 99.9% pure polycrystalline alumina. They are impervious to stains and discoloration, helping them stay transparent for the duration of the treatment. Diamante™ ceramic brackets are small and smooth, with rounded corners that provide a comfort level to the patient. Diamante™ ceramic brackets features a unique state-of-the-art dovetail base design for maximum bonding surface between the bracket and the adhesive. Successful bonding and debonding can be achieved using currently available bonding techniques.
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 | G & H Wire Company, United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K132368 |
| Record published | 2016-09-24 |
| Record revised | 2023-01-31 (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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 57-U4-2U-V | 5 | In distribution | |
| 57-U2-8R-V | 5 | In distribution | |
| 57-U3-2R-V | 5 | In distribution | |
| 57-U3-2L-V | 5 | In distribution | |
| 57-L4-2L-V | 5 | In distribution | |
| 57-L5-8LK-V | 5 | In distribution | |
| 57-L4-8RK-V | 5 | In distribution | |
| 57-U1-8R-V | 5 | In distribution | |
| 57-U3-2LK-V | 5 | In distribution | |
| 57-L4-8L-V | 5 | In distribution | |
| 57-U4-8UK-V | 5 | In distribution | |
| 57-L5-2RK-V | 5 | In distribution | |
| 57-L1-8U-V | 5 | In distribution | |
| 57-L3-2RK-V | 5 | In distribution | |
| 57-U2-2L-V | 5 | In distribution | |
| 57-U1-8L-V | 5 | In distribution | |
| 57-U1-2R-V | 5 | In distribution | |
| 57-L3-2LK-V | 5 | In distribution | |
| 57-L5-8R-V | 5 | In distribution | |
| 57-U3-8L-V | 5 | In distribution | |
| 57-L1-2U-V | 5 | In distribution | |
| 57-L3-8L-V | 5 | In distribution | |
| 57-L4-2RK-V | 5 | In distribution | |
| 57-L3-2L-V | 5 | In distribution | |
| 57-L4-2LK-V | 5 | In distribution | |
| 57-L5-2L-V | 5 | In distribution | |
| 57-L3-8L-V | 5 | In distribution | |
| 57-U3-8RK-V | 5 | In distribution | |
| 57-L5-2LK-V | 5 | In distribution | |
| 57-L5-2R-V | 5 | In distribution | |
| 57-L5-8RK-V | 5 | In distribution | |
| 57-L4-8R-V | 5 | In distribution | |
| 57-L3-2R-V | 5 | In distribution | |
| 57-U4-2UK-V | 5 | In distribution | |
| 57-L3-8RK-V | 5 | In distribution | |
| 57-U3-8R-V | 5 | In distribution | |
| 57-U3-2RK-V | 5 | In distribution | |
| 57-U4-8U-V | 5 | In distribution | |
| 57-L4-8LK-V | 5 | In distribution | |
| 57-L3-8R-V | 5 | In distribution | |
| 57-U3-8LK-V | 5 | In distribution | |
| 57-L5-8L-V | 5 | In distribution | |
| 57-U2-8L-V | 5 | In distribution | |
| 57-U1-2L-V | 5 | In distribution | |
| 57-L4-2R-V | 5 | In distribution | |
| 57-U2-2R-V | 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.