SparkTM Clear Aligner System
510(k) K250487
SparkTM Clear Aligner System is a Class II device made by Ormco Corporation, cleared under FDA 510(k) K250487 on 20 Feb 2025, 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 | NumberK250487 | Date20 Feb 2025 | StatusActive |
Official records
- FDA 510(k) database K250487
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- Withdrawn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
Similar devices
Other devices filed under FDA product code NXC (Aligner, Sequential).
- SureSmile Aligner (ASSY500020) by DENTSPLY SIRONA INC
- Additively Manufactured Aligner Resin by Aidite (Qinhuangdao) Technology Co., Ltd.
- Fas Aligner System by Xplora 3D Europe S.L
- ClearCorrect System Aligner (Multi-layer) REF03 by ClearCorrect Operating LLC
- NEOLab Clear Aligners by New England Ortho Lab, Inc.
- Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G by BLUE SKY BIO LLC
- Blue Sky Bio Aligner by BLUE SKY BIO LLC
- TERA HARZ CLEAR by Graphy Inc.
- DigiLine Direct Print Aligner System by Park Dental Research Corp
- Clear Image Aligners by Specialty Appliance Works, Inc.