Clarion™ Roth Metal-Lined Ceramic Brackets (KIT)
CLARION™ ROTH .018 HK/345 METAL-LINED CERAMIC KIT W/CASE Clarion™ ceramic brackets feature a nickel-free silver alloy-lined archwire slot, making them a safe alternative for nickel…
CLARION™ ROTH.018 HK/345 METAL-LINED CERAMIC KIT W/CASE Clarion™ ceramic brackets feature a nickel-free silver alloy-lined archwire slot, making them a safe alternative for nickel sensitive patients. The metal slot is precisely integrated into the bracket body, creating a pleasantly aesthetic device that delivers the sliding mechanics of a metal slot. The Clarion™ ceramic bracket system also features a state-of-the art dovetail base design for maximum bonding surface between the bracket and 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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2017-09-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 50K-3-22-01 | In distribution | |
| 50K-3-22-12 | In distribution | |
| 50K-3-18-01 | In distribution | |
| 50K-345-18-01 | In distribution | |
| 50K-345-22-01 | In distribution | |
| 50K-NHK-18-01 | In distribution | |
| 50K-NHK-22-01 | In distribution | |
| 50K-3-18 | Withdrawn | |
| 50K-345-22 | Withdrawn | |
| 50K-3-22 | Withdrawn | |
| 50K-345-18 | Withdrawn |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.