Clear21
Clear21 is a ceramic bracket system for fixed appliance orthodontic treatment. Its stated indication is to aid movement of teeth during orthodontic treatment. The filing describes brackets…
Clear21 is a ceramic bracket system for fixed appliance orthodontic treatment. Its stated indication is to aid movement of teeth during orthodontic treatment.
The filing describes brackets bonded directly to teeth, with a clinician-selected archwire placed in each bracket slot and secured by a self-ligating door.
Listed Item
7X7 U/L HKS 345/C21 U3X3/P21 U45/ -27/P21L
Bracket Construction
The bracket assembly includes a ceramic body and door with a nitinol spring element. The spring provides force for the ligating mechanism, and closing the door secures the archwire in its slot. The system is for clinic use.
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 | World Class Technology Corporation, United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K192202 |
| Record published | 2022-05-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 246.21559999999999 | In distribution | |
| 246.2001-5 | In distribution | |
| 246.20320000000001 | In distribution | |
| 246.2007-5 | In distribution | |
| 246.21549999999999 | In distribution | |
| 246.2011-5 | In distribution | |
| 246.2004-5 | In distribution | |
| 246.2008-5 | In distribution | |
| 246.2012-5 | In distribution | |
| 246.2002-5 | In distribution | |
| 246.20330000000001 | In distribution | |
| 246.2003-5 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192202 | 2019-11-12 |
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.