Miso
The MISO bracket is indicated for orthodontic movement of natural teeth
1manufacturer
23catalogue numbers in this listing
1510(k) clearance
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 | HT Co., Ltd., South Korea |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Record published | 2017-02-25 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Liquid Chemical |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 5, pack of 4, zipper bag of 2, pack of 8, pack of 10, box of 35 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MB181-312 | 10 | In distribution | |
| MB221-304 | 10 | In distribution | |
| MB181-455 | 10 | In distribution | |
| MB181-202 | 10 | In distribution | |
| MBS221-555 | In distribution | ||
| MB221-202 | 10 | In distribution | |
| MB181-444 | 10 | In distribution | |
| MB181-233 | 10 | In distribution | |
| MB181-144 | 10 | In distribution | |
| MB181-102 | 10 | In distribution | |
| MB181-133 | 10 | In distribution | |
| MB221-201 | 10 | In distribution | |
| MB181-244 | 10 | In distribution | |
| MBS181-553 | In distribution | ||
| MB181-433 | 10 | In distribution | |
| MB221-101 | 10 | In distribution | |
| MB181-201 | 10 | In distribution | |
| MB181-333 | 10 | In distribution | |
| MB181-101 | 10 | In distribution | |
| MB181-344 | 10 | In distribution | |
| MBS181-555 | In distribution | ||
| MB181-355 | 10 | In distribution | |
| MBS221-313 | 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 |
|---|---|
| K102561 | 2011-01-25 |
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.