Resolve® Ceramic
Resolve® Ceramic R022 UL 5-5 CS HK/MBT 4-5
1manufacturer
64catalogue 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 7) |
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 | 2021-02-19 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 210-231-61 | 10 | Withdrawn | |
| 210-211-60 | 10 | Withdrawn | |
| K210-152-12 | 20 | Withdrawn | |
| 210-331-10 | 10 | Withdrawn | |
| 210-651-60 | 10 | Withdrawn | |
| 210-652-61 | 10 | Withdrawn | |
| 210-612-60 | 10 | Withdrawn | |
| 210-432-10 | 10 | Withdrawn | |
| 210-641-10 | 10 | Withdrawn | |
| 210-122-60 | 10 | Withdrawn | |
| 210-641-61 | 10 | Withdrawn | |
| 210-212-00 | 10 | Withdrawn | |
| 210-642-10 | 10 | Withdrawn | |
| 210-652-60 | 10 | Withdrawn | |
| 210-332-61 | 10 | Withdrawn | |
| 210-222-00 | 10 | Withdrawn | |
| 210-542-61 | 10 | Withdrawn | |
| 210-642-61 | 10 | Withdrawn | |
| K210-151-81 | 10 | Withdrawn | |
| 210-131-61 | 10 | Withdrawn | |
| 210-431-61 | 10 | Withdrawn | |
| 210-221-00 | 10 | Withdrawn | |
| 210-432-61 | 10 | Withdrawn | |
| K210-151-11 | 20 | Withdrawn | |
| 210-551-61 | 10 | Withdrawn | |
| 210-232-61 | 10 | Withdrawn | |
| 210-651-10 | 10 | Withdrawn | |
| 210-611-60 | 10 | Withdrawn | |
| 210-222-60 | 10 | Withdrawn | |
| 210-112-60 | 10 | Withdrawn | |
| 210-131-10 | 10 | Withdrawn | |
| 210-431-10 | 10 | Withdrawn | |
| 210-551-60 | 10 | Withdrawn | |
| 210-111-00 | 10 | Withdrawn | |
| 210-541-10 | 10 | Withdrawn | |
| 210-542-60 | 10 | Withdrawn | |
| 210-331-61 | 10 | Withdrawn | |
| 210-132-10 | 10 | Withdrawn | |
| 210-541-61 | 10 | Withdrawn | |
| 210-231-10 | 10 | Withdrawn | |
| 210-111-60 | 10 | Withdrawn | |
| 210-212-60 | 10 | Withdrawn | |
| 210-332-10 | 10 | Withdrawn | |
| 210-112-00 | 10 | Withdrawn | |
| 210-211-00 | 10 | Withdrawn | |
| 210-132-61 | 10 | Withdrawn | |
| 210-542-10 | 10 | Withdrawn | |
| 210-651-61 | 10 | Withdrawn | |
| 210-611-00 | 10 | Withdrawn | |
| 210-652-10 | 10 | Withdrawn | |
| K210-152-11 | 20 | Withdrawn | |
| 210-642-60 | 10 | Withdrawn | |
| 210-121-00 | 10 | Withdrawn | |
| 210-552-60 | 10 | Withdrawn | |
| 210-612-00 | 10 | Withdrawn | |
| 210-221-60 | 10 | Withdrawn | |
| 210-232-10 | 10 | Withdrawn | |
| 210-552-61 | 10 | Withdrawn | |
| 210-122-00 | 10 | Withdrawn | |
| K210-152-81 | 20 | Withdrawn | |
| 210-121-60 | 10 | Withdrawn | |
| K210-151-12 | 20 | Withdrawn | |
| 210-541-60 | 10 | Withdrawn | |
| 210-641-60 | 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.