Mystique® MB
MYSTIQUE® MB Roncone 018/U4&5 -10T 4A 2D HK
1manufacturer
75catalogue 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 | 2024-04-05 (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 | 2021-01-15 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 110-121-00 | 10 | Withdrawn | |
| 110-432-91 | 10 | Withdrawn | |
| 110-132-10 | 10 | Withdrawn | |
| 110-242-91 | 10 | Withdrawn | |
| 110-132-16 | 10 | Withdrawn | |
| 110-242-90 | 10 | Withdrawn | |
| 110-432-00 | 10 | Withdrawn | |
| K110-532-10 | 16 | Withdrawn | |
| 110-132-90 | 10 | Withdrawn | |
| K110-152-10 | 10 | Withdrawn | |
| 110-111-90 | 10 | Withdrawn | |
| 110-331-90 | 10 | Withdrawn | |
| 110-431-90 | 10 | Withdrawn | |
| 110-131-00 | 10 | Withdrawn | |
| 110-212-00 | 10 | Withdrawn | |
| 110-142-91 | 10 | Withdrawn | |
| 110-112-00 | 10 | Withdrawn | |
| 110-612-90 | 10 | Withdrawn | |
| 110-131-90 | 10 | Withdrawn | |
| 110-212-90 | 10 | Withdrawn | |
| 110-142-10 | 10 | Withdrawn | |
| 110-432-90 | 10 | Withdrawn | |
| 110-112-90 | 10 | Withdrawn | |
| 110-231-00 | 10 | Withdrawn | |
| 110-332-91 | 10 | Withdrawn | |
| 110-242-00 | 10 | Withdrawn | |
| 110-121-90 | 10 | Withdrawn | |
| 110-141-90 | 10 | Withdrawn | |
| 110-231-90 | 10 | Withdrawn | |
| 110-331-91 | 10 | Withdrawn | |
| 110-232-00 | 10 | Withdrawn | |
| K110-531-10 | 16 | Withdrawn | |
| 110-122-00 | 10 | Withdrawn | |
| 110-211-00 | 10 | Withdrawn | |
| 110-231-91 | 10 | Withdrawn | |
| 110-611-90 | 10 | Withdrawn | |
| 110-231-16 | 10 | Withdrawn | |
| 110-141-00 | 10 | Withdrawn | |
| 110-431-10 | 10 | Withdrawn | |
| 110-131-91 | 10 | Withdrawn | |
| 110-132-91 | 10 | Withdrawn | |
| 110-431-00 | 10 | Withdrawn | |
| 110-232-91 | 10 | Withdrawn | |
| 110-141-10 | 10 | Withdrawn | |
| 110-222-90 | 10 | Withdrawn | |
| 110-142-90 | 10 | Withdrawn | |
| 110-332-90 | 10 | Withdrawn | |
| 110-222-91 | 10 | Withdrawn | |
| 110-331-00 | 10 | Withdrawn | |
| 110-332-00 | 10 | Withdrawn | |
| 110-331-10 | 10 | Withdrawn | |
| 110-241-90 | 10 | Withdrawn | |
| 110-221-00 | 10 | Withdrawn | |
| K110-151-10 | 10 | Withdrawn | |
| 110-431-91 | 10 | Withdrawn | |
| 110-232-10 | 10 | Withdrawn | |
| 110-241-91 | 10 | Withdrawn | |
| K110-531-11 | 16 | Withdrawn | |
| 110-241-10 | 10 | Withdrawn | |
| 110-122-90 | 10 | Withdrawn | |
| 110-122-91 | 10 | Withdrawn | |
| 110-222-00 | 10 | Withdrawn | |
| 110-141-91 | 10 | Withdrawn | |
| 110-221-91 | 10 | Withdrawn | |
| 110-132-00 | 10 | Withdrawn | |
| 110-111-00 | 10 | Withdrawn | |
| 110-142-00 | 10 | Withdrawn | |
| 110-211-90 | 10 | Withdrawn | |
| 110-241-00 | 10 | Withdrawn | |
| 110-121-91 | 10 | Withdrawn | |
| 110-232-16 | 10 | Withdrawn | |
| 110-131-16 | 10 | Withdrawn | |
| 110-221-90 | 10 | Withdrawn | |
| 110-131-10 | 10 | Withdrawn | |
| 110-232-90 | 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.