Ovation® C Euro
Ovation® C Euro 022 U5-5/L3-3 CS HK
1manufacturer
24catalogue 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 | Dentsply Sirona Orthodontics Inc., 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, Manufacturer |
| Record published | 2017-06-26 |
| Record revised | 2024-04-04 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Distribution end date | 2021-09-20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 310-121-80 | 10 | Withdrawn | |
| 310-221-80 | 10 | Withdrawn | |
| 310-222-80 | 10 | Withdrawn | |
| 310-132-81 | 10 | Withdrawn | |
| K310-151-80 | 10 | Withdrawn | |
| K310-152-80 | 10 | Withdrawn | |
| 310-131-81 | 10 | Withdrawn | |
| 310-432-81 | 10 | Withdrawn | |
| 310-231-81 | 10 | Withdrawn | |
| 310-211-80 | 10 | Withdrawn | |
| 310-332-81 | 10 | Withdrawn | |
| 310-111-80 | 10 | Withdrawn | |
| 310-542-80 | 10 | Withdrawn | |
| 310-612-80 | 10 | Withdrawn | |
| 310-431-81 | 10 | Withdrawn | |
| K310-532-80 | 16 | Withdrawn | |
| K310-531-80 | 16 | Withdrawn | |
| 310-232-81 | 10 | Withdrawn | |
| 310-541-80 | 10 | Withdrawn | |
| 310-112-80 | 10 | Withdrawn | |
| 310-611-80 | 10 | Withdrawn | |
| 310-122-80 | 10 | Withdrawn | |
| 310-331-81 | 10 | Withdrawn | |
| 310-212-80 | 10 | Withdrawn |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.