NeoCrystal Plus
NeoCrystal Plus .018 Kit U/L 5x5 MC (0T) HKS
1manufacturer
92catalogue 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 | 2016-09-24 |
| Record revised | 2025-12-30 (version 6) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 715-359-5 | In distribution | |
| 715-392HK-5 | In distribution | |
| 715-391HK-5 | In distribution | |
| 715-399Q | In distribution | |
| 715-369HK-5 | In distribution | |
| 715-394-5 | In distribution | |
| 715-205-5 | In distribution | |
| 715-398Q | In distribution | |
| 715-389HK-5 | In distribution | |
| 715-259HK-5 | In distribution | |
| 715-290HK-5 | In distribution | |
| 715-258HK-5 | In distribution | |
| 715-289-5 | In distribution | |
| 715-204-5 | In distribution | |
| 715-223-5 | In distribution | |
| 715-099MCQ | In distribution | |
| 715-359HK-5 | In distribution | |
| 715-305-5 | In distribution | |
| 715-394HK-5 | In distribution | |
| 715-392-5 | In distribution | |
| 715-056HK-5 | In distribution | |
| 715-206-5 | In distribution | |
| 715-235-5 | In distribution | |
| 715-221-5 | In distribution | |
| 715-299Q | In distribution | |
| 715-387HK-5 | In distribution | |
| 715-335-5 | In distribution | |
| 715-198MCQ | In distribution | |
| 715-351HK-5 | In distribution | |
| 715-287HK-5 | In distribution | |
| 715-360-5 | In distribution | |
| 715-358-5 | In distribution | |
| 715-371HK-5 | In distribution | |
| 715-260-5 | In distribution | |
| 715-303-5 | In distribution | |
| 715-324-5 | In distribution | |
| 715-389-5 | In distribution | |
| 715-333-5 | In distribution | |
| 715-306-5 | In distribution | |
| 715-323-5 | In distribution | |
| 715-252HK-5 | In distribution | |
| 715-387-5 | In distribution | |
| 715-291-5 | In distribution | |
| 715-391-5 | In distribution | |
| 715-293HK-5 | In distribution | |
| 715-098MCQ | In distribution | |
| 715-294HK-5 | In distribution | |
| 715-357-5 | In distribution | |
| 715-388-5 | In distribution | |
| 715-222-5 | In distribution | |
| 715-390-5 | In distribution | |
| 715-357HK-5 | In distribution | |
| 715-203-5 | In distribution | |
| 715-251HK-5 | In distribution | |
| 715-290-5 | In distribution | |
| 715-257HK-5 | In distribution | |
| 715-393HK-5 | In distribution | |
| 715-358HK-5 | In distribution | |
| 715-289HK-5 | In distribution | |
| 715-292-5 | In distribution | |
| 715-224-5 | In distribution | |
| 715-288-5 | In distribution | |
| 715-272HK-5 | In distribution | |
| 715-260HK-5 | In distribution | |
| 715-269HK-5 | In distribution | |
| 715-293-5 | In distribution | |
| 715-199MCQ | In distribution | |
| 715-372HK-5 | In distribution | |
| 715-155HK-5 | In distribution | |
| 715-292HK-5 | In distribution | |
| 715-298Q | In distribution | |
| 715-233-5 | In distribution | |
| 715-321-5 | In distribution | |
| 715-258-5 | In distribution | |
| 715-288HK-5 | In distribution | |
| 715-271HK-5 | In distribution | |
| 715-055HK-5 | In distribution | |
| 715-360HK-5 | In distribution | |
| 715-156HK-5 | In distribution | |
| 715-270HK-5 | In distribution | |
| 715-393-5 | In distribution | |
| 715-291HK-5 | In distribution | |
| 715-352HK-5 | In distribution | |
| 715-287-5 | In distribution | |
| 715-257-5 | In distribution | |
| 715-259-5 | In distribution | |
| 715-322-5 | In distribution | |
| 715-390HK-5 | In distribution | |
| 715-294-5 | In distribution | |
| 715-388HK-5 | In distribution | |
| 715-304-5 | In distribution | |
| 715-370HK-5 | 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.