Reflections
Reflections V-Slot 022 LR3 Hk Roth Rx -11° Tor. +5° Ang.(10PK)
1manufacturer
105catalogue 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) | K922499 |
| 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 |
|---|---|---|
| RFM18-1300 | In distribution | |
| REF-851 | In distribution | |
| REF-131 | In distribution | |
| RF22-1000 | In distribution | |
| REF-852 | In distribution | |
| RFV1822-1345 | In distribution | |
| RF22-2300 | In distribution | |
| REF-012 | In distribution | |
| REF-123 | In distribution | |
| REF-811 | In distribution | |
| RF18360 | In distribution | |
| REF-171 | In distribution | |
| RF22-2345 | In distribution | |
| REF-122 | In distribution | |
| REF-862 | In distribution | |
| RFM22-1345 | In distribution | |
| REF-121 | In distribution | |
| REF-830 | In distribution | |
| REF-571 | In distribution | |
| REF-871 | In distribution | |
| REF-022 | In distribution | |
| REF-070 | In distribution | |
| REF-061 | In distribution | |
| REF-111 | In distribution | |
| REF-863 | In distribution | |
| RF18-2345 | In distribution | |
| REF-872 | In distribution | |
| RF22-1345 | In distribution | |
| RF18370 | In distribution | |
| REF-801 | In distribution | |
| REF-812 | In distribution | |
| REF-841 | In distribution | |
| REF-160 | In distribution | |
| RFM18-1345 | In distribution | |
| REF-002 | In distribution | |
| RF22320 | In distribution | |
| REF-011 | In distribution | |
| REF-112 | In distribution | |
| REF-071 | In distribution | |
| RF18-2300 | In distribution | |
| REF-030 | In distribution | |
| REF-051 | In distribution | |
| REF-031 | In distribution | |
| REF-874 | In distribution | |
| REF-130 | In distribution | |
| RF18-300 | In distribution | |
| REF-864 | In distribution | |
| RFM22-1300 | In distribution | |
| RF22-300 | In distribution | |
| REF-001 | In distribution | |
| RF18-1300 | In distribution | |
| REF-060 | In distribution | |
| REF-052 | In distribution | |
| RF18320 | In distribution | |
| REF-802 | In distribution | |
| RF1822-1345 | In distribution | |
| RF22360 | In distribution | |
| REF-021 | In distribution | |
| REF-170 | In distribution | |
| REF-102 | In distribution | |
| RF22-1300 | In distribution | |
| REF-831 | In distribution | |
| REF-041 | In distribution | |
| REF-873 | In distribution | |
| REF-822 | In distribution | |
| REF-151 | In distribution | |
| REF-152 | In distribution | |
| REF-161 | In distribution | |
| RF22370 | In distribution | |
| REF-821 | In distribution | |
| REF-101 | In distribution | |
| REF-141 | In distribution | |
| REF-861 | In distribution | |
| RF18-1345 | In distribution | |
| REF-320 | Withdrawn | |
| REF-612 | Withdrawn | |
| REF-621 | Withdrawn | |
| RF322-1345 | Withdrawn | |
| REF-602 | Withdrawn | |
| REF-300 | Withdrawn | |
| REF-651 | Withdrawn | |
| REF-340 | Withdrawn | |
| REF-631 | Withdrawn | |
| REF-671 | Withdrawn | |
| REF-210 | Withdrawn | |
| REF-220 | Withdrawn | |
| REF-611 | Withdrawn | |
| RF118-1345 | Withdrawn | |
| REF-230 | Withdrawn | |
| RFM18-300 | Withdrawn | |
| RFM22-300 | Withdrawn | |
| REF-601 | Withdrawn | |
| REF-200 | Withdrawn | |
| REF-310 | Withdrawn | |
| REF-640 | Withdrawn | |
| REF-652 | Withdrawn | |
| REF-622 | Withdrawn | |
| REF-670 | Withdrawn | |
| REF-661 | Withdrawn | |
| REF-660 | Withdrawn | |
| REF-240 | Withdrawn | |
| REF-630 | Withdrawn | |
| REF-330 | Withdrawn | |
| RF222-1000 | Withdrawn | |
| RF322-1300 | 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.