Vapor™ MBT Ceramic Brackets
VAPOR™ MBT .022 UL4/5 HK -7°T 0°A Vapor™ brackets are nearly invisible polycrystalline Ceramic Brackets manufactured through Ceramic Injected Molded – (CIM) Manufacturing. They are…
VAPOR™ MBT.022 UL4/5 HK -7°T 0°A Vapor™ brackets are nearly invisible polycrystalline Ceramic Brackets manufactured through Ceramic Injected Molded → (CIM) Manufacturing. They are translucent in appearance, and aesthetically pleasing. They have a revolutionary “Portal” Bonding Base; so adhesive flows through portals in the base for unprecedented mechanical bonds and optimal debonds.
1manufacturer
76catalogue 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 | 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 |
| Distribution end date | 2017-09-14 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 76-L3-8LK0-V | 5 | In distribution | |
| 76-U3-8RK-V | 5 | In distribution | |
| 76-L5-2RK-V | 5 | In distribution | |
| 76-U4-2LK-V | 5 | In distribution | |
| 76-L4-2LK-V | 5 | In distribution | |
| 76-U4-8U-V | 5 | In distribution | |
| 76-L3-2RK-V | 5 | In distribution | |
| 76-L4-2U-V | 5 | In distribution | |
| 76-L4-2RK-V | 5 | In distribution | |
| 76-L3-2LK0-V | 5 | In distribution | |
| 76-L5-8LK-V | 5 | In distribution | |
| 76-U1-2R-V | 5 | In distribution | |
| 76-U4-2RK-V | 5 | In distribution | |
| 76-U3-8LK0-V | 5 | In distribution | |
| 76-L3-8RK-V | 5 | In distribution | |
| 76-L4-8U-V | 5 | In distribution | |
| 76-U1-8R-V | 5 | In distribution | |
| 76-U4-8LK-V | 5 | In distribution | |
| 76-L5-8U-V | 5 | In distribution | |
| 76-U3-2LK0-V | 5 | In distribution | |
| 76-L1-2U-V | 5 | In distribution | |
| 76-U3-2RK-V | 5 | In distribution | |
| 76-L4-8RK-V | 5 | In distribution | |
| 76-U2-2L-V | 5 | In distribution | |
| 76-U3-8RK0-V | 5 | In distribution | |
| 76-U2-2R-V | 5 | In distribution | |
| 76-U3-2RK0-V | 5 | In distribution | |
| 76-U2-8R-V | 5 | In distribution | |
| 76-U1-8L-V | 5 | In distribution | |
| 76-U3-8LK-V | 5 | In distribution | |
| 76-U4-8RK-V | 5 | In distribution | |
| 76-L1-8U-V | 5 | In distribution | |
| 76-L4-8LK-V | 5 | In distribution | |
| 76-L3-2LK-V | 5 | In distribution | |
| 76-L3-8LK-V | 5 | In distribution | |
| 76-L5-2U-V | 5 | In distribution | |
| 76-U4-2U-V | 5 | In distribution | |
| 76-L3-8RK0-V | 5 | In distribution | |
| 76-U1-2L-V | 5 | In distribution | |
| 76-L5-8RK-V | 5 | In distribution | |
| 76-U2-8L-V | 5 | In distribution | |
| 76-L5-2LK-V | 5 | In distribution | |
| 76-U3-2LK-V | 5 | In distribution | |
| 76-L3-2RK0-V | 5 | In distribution | |
| 76-U1-8RF-V | 5 | Withdrawn | |
| 76-U1-2RF-V | 5 | Withdrawn | |
| 76-L5-8LKF-V | 5 | Withdrawn | |
| 76-L5-2RKF-V | 5 | Withdrawn | |
| 76-L3-8RK0F-V | 5 | Withdrawn | |
| 76-L3-8LK0F-V | 5 | Withdrawn | |
| 76-L5-8UF-V | 5 | Withdrawn | |
| 76-L5-8RKF-V | 5 | Withdrawn | |
| 76-U1-8LF-V | 5 | Withdrawn | |
| 76-U4-8UF-V | 5 | Withdrawn | |
| 76-U2-2RF-V | 5 | Withdrawn | |
| 76-U3-8LK0F-V | 5 | Withdrawn | |
| 76-U3-8RK0F-V | 5 | Withdrawn | |
| 76-L5-2LKF-V | 5 | Withdrawn | |
| 76-U3-2RK0F-V | 5 | Withdrawn | |
| 76-L4-2LKF-V | 5 | Withdrawn | |
| 76-L3-2RK0F-V | 5 | Withdrawn | |
| 76-U2-8RF-V | 5 | Withdrawn | |
| 76-U4-2RKF-V | 5 | Withdrawn | |
| 76-U4-8RKF-V | 5 | Withdrawn | |
| 76-U1-2LF-V | 5 | Withdrawn | |
| 76-L4-2RKF-V | 5 | Withdrawn | |
| 76-U4-2LKF-V | 5 | Withdrawn | |
| 76-L3-2LK0F-V | 5 | Withdrawn | |
| 76-U4-8LKF-V | 5 | Withdrawn | |
| 76-U2-8LF-V | 5 | Withdrawn | |
| 76-L1-2UF-V | 5 | Withdrawn | |
| 76-L1-8UF-V | 5 | Withdrawn | |
| 76-U3-2LK0F-V | 5 | Withdrawn | |
| 76-U2-2LF-V | 5 | Withdrawn | |
| 76-L5-2UF-V | 5 | Withdrawn | |
| 76-U4-2UF-V | 5 | 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
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.