Cleo
Cleo is a ceramic bracket line intended to work with other orthodontic devices to apply forces to teeth. The filing describes this use under the supervision of a trained dental professional…
Cleo is a ceramic bracket line intended to work with other orthodontic devices to apply forces to teeth. The filing describes this use under the supervision of a trained dental professional or orthodontist.
The filing indicates the Cleo bracket line for orthodontic treatment of malocclusions and craniofacial abnormalities diagnosed by a trained dental professional or orthodontist. It describes the brackets as prescription-use and single-use devices.
Listed Item
Cosmetic Cleo UL BIC 018 T-7 A=0 R=0 W/HK Dist
Use and Handling
The filing names the diagnosis context and specifies prescription and single-use status for the Cleo bracket line.
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 | American Orthodontics, United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K232011 |
| Record published | 2024-12-30 |
| Record revised | 2025-01-15 (version 2) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2025-02-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 002-22-000010 | Withdrawn | |
| 002-18-000010HD | Withdrawn | |
| 002-22-000010HM | Withdrawn | |
| 002-22-000009HD | Withdrawn | |
| 002-22-000009 | Withdrawn | |
| 002-22-000010 | Withdrawn | |
| 002-18-000009HM | Withdrawn | |
| 002-18-000009 | Withdrawn | |
| 002-18-000010HD | Withdrawn | |
| 002-22-000009HM | Withdrawn | |
| 002-18-000009HD | Withdrawn | |
| 002-18-000009HM | Withdrawn | |
| 002-18-000010 | Withdrawn | |
| 002-22-000009HD | Withdrawn | |
| 002-18-000009HD | Withdrawn | |
| 002-18-000009 | Withdrawn | |
| 002-18-000010 | Withdrawn | |
| 002-18-000010HM | Withdrawn | |
| 002-22-000010HM | Withdrawn | |
| 002-22-000010HD | Withdrawn | |
| 002-22-000009 | Withdrawn | |
| 002-22-000009HM | Withdrawn | |
| 002-18-000010HM | Withdrawn | |
| 002-22-000010HD | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232011 | 2023-07-07 |
| K122753 | 2012-12-14 |
| K080749 | 2008-08-04 |
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.