Venus Roth Ceramic Brackets
Venus Roth Crmc LWR 4 UNIV.018. Ceramic Bracket.
1manufacturer
38catalogue 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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| VCRU418-V | 5 | In distribution | |
| VCRU422-V | 5 | In distribution | |
| VCRLL323-V | 5 | In distribution | |
| VCRUL222-V | 5 | In distribution | |
| VCRUR322-V | 5 | In distribution | |
| VCRUL318-V | 5 | In distribution | |
| VCRL522-V | 5 | In distribution | |
| VCRL419-V | 5 | In distribution | |
| VCRL418-V | 5 | In distribution | |
| VCRUR118-V | 5 | In distribution | |
| VCRLR118-V | 5 | In distribution | |
| VCRU419-V | 5 | In distribution | |
| VCRUR122-V | 5 | In distribution | |
| VCRLL318-V | 5 | In distribution | |
| VCRL422-V | 5 | In distribution | |
| VCRU423-V | 5 | In distribution | |
| VCRUL122-V | 5 | In distribution | |
| VCRUR318-V | 5 | In distribution | |
| VCRLR323-V | 5 | In distribution | |
| VCRUR222-V | 5 | In distribution | |
| VCRUR323-V | 5 | In distribution | |
| VCRUL323-V | 5 | In distribution | |
| VCRUR218-V | 5 | In distribution | |
| VCRL423-V | 5 | In distribution | |
| VCRL523-V | 5 | In distribution | |
| VCRLR122-V | 5 | In distribution | |
| VCRLL319-V | 5 | In distribution | |
| VCRLR318-V | 5 | In distribution | |
| VCRLR319-V | 5 | In distribution | |
| VCRUL319-V | 5 | In distribution | |
| VCRL519-V | 5 | In distribution | |
| VCRLR322-V | 5 | In distribution | |
| VCRUL322-V | 5 | In distribution | |
| VCRUR319-V | 5 | In distribution | |
| VCRUL218-V | 5 | In distribution | |
| VCRLL322-V | 5 | In distribution | |
| VCRL518-V | 5 | In distribution | |
| VCRUL118-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.