Pure®
PURE® McLaughlin .022 UL 4/5 Hk Rx -7° Tor. 0° Ang.(10PK)
1manufacturer
72catalogue 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 | Ortho Organizers, Inc., United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K073045 |
| Record published | 2025-09-26 |
| Record revised | 2025-12-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| S18062 | 10 | In distribution | |
| S22171 | 10 | In distribution | |
| S22450 | In distribution | ||
| S18032 | 10 | In distribution | |
| S22871 | 10 | In distribution | |
| S22131 | 10 | In distribution | |
| S22841 | 10 | In distribution | |
| S22802 | 10 | In distribution | |
| S18051 | 10 | In distribution | |
| S22874 | 10 | In distribution | |
| S22870 | In distribution | ||
| S22862 | 10 | In distribution | |
| S22151 | 10 | In distribution | |
| S18300 | In distribution | ||
| S22800 | In distribution | ||
| S22822 | 10 | In distribution | |
| S22812 | 10 | In distribution | |
| S18030 | 10 | In distribution | |
| S22833 | 10 | In distribution | |
| S22873 | 10 | In distribution | |
| S22370 | In distribution | ||
| S18001 | 10 | In distribution | |
| S22832 | 10 | In distribution | |
| S22864 | 10 | In distribution | |
| S22121 | 10 | In distribution | |
| S22300 | In distribution | ||
| S22330 | In distribution | ||
| S22831 | 10 | In distribution | |
| S18072 | 10 | In distribution | |
| S22801 | 10 | In distribution | |
| S22160 | 10 | In distribution | |
| S22360 | In distribution | ||
| S22122 | 10 | In distribution | |
| S22162 | 10 | In distribution | |
| S18340 | In distribution | ||
| S18370 | In distribution | ||
| S18012 | 10 | In distribution | |
| S22141 | 10 | In distribution | |
| S22840 | In distribution | ||
| S22863 | 10 | In distribution | |
| S22161 | 10 | In distribution | |
| S22852 | 10 | In distribution | |
| S22101 | 10 | In distribution | |
| S18031 | 10 | In distribution | |
| S22340 | In distribution | ||
| S22112 | 10 | In distribution | |
| S22132 | 10 | In distribution | |
| S18041 | 10 | In distribution | |
| S22872 | 10 | In distribution | |
| S18060 | 10 | In distribution | |
| S18450 | In distribution | ||
| S18071 | 10 | In distribution | |
| S22111 | 10 | In distribution | |
| S22170 | 10 | In distribution | |
| S22152 | 10 | In distribution | |
| S18022 | 10 | In distribution | |
| S22811 | 10 | In distribution | |
| S22172 | 10 | In distribution | |
| S22851 | 10 | In distribution | |
| S22130 | 10 | In distribution | |
| S22102 | 10 | In distribution | |
| S18002 | 10 | In distribution | |
| S18052 | 10 | In distribution | |
| S22860 | In distribution | ||
| S22830 | In distribution | ||
| S22861 | 10 | In distribution | |
| S18061 | 10 | In distribution | |
| S18330 | In distribution | ||
| S18070 | 10 | In distribution | |
| S22821 | 10 | In distribution | |
| S18021 | 10 | In distribution | |
| S18011 | 10 | 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 |
|---|---|
| K173440 | 2018-03-08 |
| K110335 | 2011-05-19 |
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.