Pure
PURE® McLaughlin 022 UR 4/5 Hk Rx -7º Tor. 0º Ang.(10PK)
1manufacturer
113catalogue 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 Technology, Inc., United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| 510(k) | K073045 |
| Record published | 2016-09-24 |
| Record revised | 2024-12-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2024-09-18 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S22330 | In distribution | |
| S22830 | In distribution | |
| S22851 | In distribution | |
| S18001 | In distribution | |
| S22400 | In distribution | |
| S18440 | In distribution | |
| S18060 | In distribution | |
| S18072 | In distribution | |
| S22801 | In distribution | |
| S22853 | In distribution | |
| S22141 | In distribution | |
| S18340 | In distribution | |
| S18052 | In distribution | |
| S22863 | In distribution | |
| S22824 | In distribution | |
| S22823 | In distribution | |
| S18053 | In distribution | |
| S22873 | In distribution | |
| S22360 | In distribution | |
| S22872 | In distribution | |
| S18071 | In distribution | |
| S18021 | In distribution | |
| S22410 | In distribution | |
| S22130 | In distribution | |
| S22861 | In distribution | |
| S18022 | In distribution | |
| S22151 | In distribution | |
| S22450 | In distribution | |
| S18011 | In distribution | |
| S18041 | In distribution | |
| S18420 | In distribution | |
| S22812 | In distribution | |
| S18400 | In distribution | |
| S22421 | In distribution | |
| S22154 | In distribution | |
| S18410 | In distribution | |
| S1822330 | In distribution | |
| S22811 | In distribution | |
| S22831 | In distribution | |
| S22123 | In distribution | |
| S18421 | In distribution | |
| S18422 | In distribution | |
| S22840 | In distribution | |
| S18024 | In distribution | |
| S18062 | In distribution | |
| S22430 | In distribution | |
| S22833 | In distribution | |
| S22874 | In distribution | |
| S22132 | In distribution | |
| S22101 | In distribution | |
| S22111 | In distribution | |
| S22131 | In distribution | |
| S22160 | In distribution | |
| S22822 | In distribution | |
| S18012 | In distribution | |
| S22841 | In distribution | |
| S18070 | In distribution | |
| S22102 | In distribution | |
| S22121 | In distribution | |
| S18061 | In distribution | |
| S22162 | In distribution | |
| S22852 | In distribution | |
| S18002 | In distribution | |
| S22800 | In distribution | |
| S18450 | In distribution | |
| S22300 | In distribution | |
| S18430 | In distribution | |
| S22864 | In distribution | |
| S22854 | In distribution | |
| S22161 | In distribution | |
| S22802 | In distribution | |
| S18300 | In distribution | |
| S22440 | In distribution | |
| S22870 | In distribution | |
| S22832 | In distribution | |
| S22172 | In distribution | |
| S22370 | In distribution | |
| S22112 | In distribution | |
| S18054 | In distribution | |
| S22153 | In distribution | |
| S22152 | In distribution | |
| S18330 | In distribution | |
| S18031 | In distribution | |
| S18051 | In distribution | |
| S22821 | In distribution | |
| S22122 | In distribution | |
| S22171 | In distribution | |
| S22170 | In distribution | |
| S18030 | In distribution | |
| S22862 | In distribution | |
| S22871 | In distribution | |
| S18370 | In distribution | |
| S18032 | In distribution | |
| S22340 | In distribution | |
| S22860 | In distribution | |
| S18360 | Withdrawn | |
| S22850 | Withdrawn | |
| S22350 | Withdrawn | |
| S18310 | Withdrawn | |
| S18320 | Withdrawn | |
| S18023 | Withdrawn | |
| S22380 | Withdrawn | |
| S22390 | Withdrawn | |
| S22820 | Withdrawn | |
| S22320 | Withdrawn | |
| S22100 | Withdrawn | |
| S22124 | Withdrawn | |
| S22810 | Withdrawn | |
| S18350 | Withdrawn | |
| S22420 | Withdrawn | |
| S18100 | Withdrawn | |
| S22310 | Withdrawn | |
| S22422 | 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 |
|---|---|
| K112707 | 2012-01-13 |
| K073045 | 2007-12-18 |
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.