Magic Clear Aligners
510(k) K190948
Magic Clear Aligners is a medical device (FDA Class II; FDA product code NXC, Aligner, Sequential) made by Voodoo Manufacturing, Inc., cleared under FDA 510(k) K190948 on 9 May 2019, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK190948 | Date9 May 2019 | StatusActive |
Official records
- FDA 510(k) database K190948
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NXC
- Device class
- Class II
- Regulation
- 21 CFR Part 872.5470
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K190948
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| CandidPro FGS-0002 | FGS-0002 | 00850004223253 | — | On the market |
| CandidPro FGS-0004 | FGS-0004 | 00850004223260 | — | On the market |
| CandidPro FGS-0008 | FGS-0008 | 00850004223550 | — | On the market |
| CandidPro FGS-0025 | FGS-0025 | 00850004223307 | — | On the market |
| CandidPro FGS-0026 | FGS-0026 | 00850004223413 | — | On the market |
| Oliv Aligner FGS-3002 | FGS-3002 | 00850004223376 | — | On the market |
| Oliv FGS-3004 | FGS-3004 | 00850004223383 | — | On the market |
| Oliv FGS-3008 | FGS-3008 | 00850004223390 | — | On the market |
| Oliv FGS-3025 | FGS-3025 | 00850004223468 | — | On the market |
| Oliv FGS-3026 | FGS-3026 | 00850004223475 | — | On the market |
| Oliv Sprouts FGS-3033 | FGS-3033 | 00850004223512 | — | On the market |
| Oliv Sprouts FGS-3035 | FGS-3035 | 00850004223529 | — | On the market |
| ProMonitoring FGS-2002 | FGS-2002 | 00850004223314 | — | On the market |
| ProMonitoring FGS-2004 | FGS-2004 | 00850004223994 | — | On the market |
| ProMonitoring FGS-2008 | FGS-2008 | 00850004223352 | — | On the market |
| Voodoo Clear Aligners 1 | 1 | 00860000937801 | — | On the market |
Similar devices
Other devices filed under FDA product code NXC (Aligner, Sequential).
- DailyMate Orthodontic Aligner System by 3D Global Biotech, Inc.
- PONTIC PAINT by RELIANCE ORTHODONTIC PRODUCTS, INC.
- Clear Aligner by Shenzhen Meiming Dentistry Technology Co., Ltd.
- Orthodontic Appliance by Shandong Huge Dental Material Corporation
- Clear-Aligners by Cdb Corporation
- 3M Clarity Aligners by 3M COMPANY
- Al Smile Aligner by Nanjing Jiahe Dental Technology co. LTD
- TERA HARZ CLEAR TR-07 NONE by Graphy Inc.
- CLEARCORRECT SYSTEM by Clearcorrect, Inc.
- 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) by 3M Company, Unitek Orthodontic Products