Clarity™ SL
Clarity(TM) SL Self-Ligating Bracket High Torque VPO UL4,5 -4T/0A Hk .022 5/Pk
1manufacturer
87catalogue numbers in this listing
2510(k) clearances naming this product code
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 | 3M Unitek, United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| 510(k) | K062305 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2017-01-21 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 007-509 | 5 | In distribution | |
| 007-110 | In distribution | ||
| 007-451 | 5 | In distribution | |
| 007-439 | 5 | In distribution | |
| 007-440 | 5 | In distribution | |
| 007-447 | 5 | In distribution | |
| 007-540 | 5 | In distribution | |
| 007-532 | 5 | In distribution | |
| 007-412 | 5 | In distribution | |
| 007-531 | 5 | In distribution | |
| 007-420 | 5 | In distribution | |
| 007-135 | In distribution | ||
| 007-100 | In distribution | ||
| 007-403 | 5 | In distribution | |
| 007-503 | 5 | In distribution | |
| 007-401 | 5 | In distribution | |
| 007-404 | 5 | In distribution | |
| 007-424 | 5 | In distribution | |
| 007-508 | 5 | In distribution | |
| 007-512 | 5 | In distribution | |
| 007-432 | 5 | In distribution | |
| 007-452 | 5 | In distribution | |
| 007-450 | 5 | In distribution | |
| 007-421 | 5 | In distribution | |
| 007-507 | 5 | In distribution | |
| 007-523 | 5 | In distribution | |
| 007-431 | 5 | In distribution | |
| 007-152 | In distribution | ||
| 007-544 | 5 | In distribution | |
| 007-417 | 5 | In distribution | |
| 007-445 | 5 | In distribution | |
| 007-443 | 5 | In distribution | |
| 007-522 | 5 | In distribution | |
| 007-411 | 5 | In distribution | |
| 007-402 | 5 | In distribution | |
| 007-142 | In distribution | ||
| 007-502 | 5 | In distribution | |
| 007-430 | 5 | In distribution | |
| 007-136 | In distribution | ||
| 007-130 | In distribution | ||
| 007-548 | 5 | In distribution | |
| 007-518 | 5 | In distribution | |
| 007-423 | 5 | In distribution | |
| 007-448 | 5 | In distribution | |
| 007-524 | 5 | In distribution | |
| 007-511 | 5 | In distribution | |
| 007-408 | 5 | In distribution | |
| 007-405 | 5 | In distribution | |
| 007-125 | In distribution | ||
| 007-446 | 5 | In distribution | |
| 007-542 | 5 | In distribution | |
| 007-134 | In distribution | ||
| 007-107 | In distribution | ||
| 007-506 | 5 | In distribution | |
| 007-547 | 5 | In distribution | |
| 007-539 | 5 | In distribution | |
| 007-444 | 5 | In distribution | |
| 007-549 | 5 | In distribution | |
| 007-406 | 5 | In distribution | |
| 007-504 | 5 | In distribution | |
| 007-530 | 5 | In distribution | |
| 007-409 | 5 | In distribution | |
| 007-543 | 5 | In distribution | |
| 007-132 | In distribution | ||
| 007-552 | 5 | In distribution | |
| 007-122 | In distribution | ||
| 007-123 | In distribution | ||
| 007-519 | 5 | In distribution | |
| 007-520 | 5 | In distribution | |
| 007-418 | 5 | In distribution | |
| 007-550 | 5 | In distribution | |
| 007-117 | In distribution | ||
| 007-419 | 5 | In distribution | |
| 007-521 | 5 | In distribution | |
| 007-407 | 5 | In distribution | |
| 007-441 | 5 | In distribution | |
| 007-505 | 5 | In distribution | |
| 007-501 | 5 | In distribution | |
| 007-541 | 5 | In distribution | |
| 007-126 | In distribution | ||
| 007-449 | 5 | In distribution | |
| 007-442 | 5 | In distribution | |
| 007-422 | 5 | In distribution | |
| 007-551 | 5 | In distribution | |
| 007-133 | In distribution | ||
| 007-120 | Withdrawn | ||
| 007-517 | 5 | 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 |
|---|---|
| K102803 | 2011-02-17 |
| K062305 | 2006-10-18 |
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.