Spark™ Clear Aligner System
510(k) K240501
Spark™ Clear Aligner System is a Class II device made by Ormco Corporation, cleared under FDA 510(k) K240501 on 11 Oct 2024, active as of 25 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 | NumberK240501 | Date11 Oct 2024 | StatusActive |
Official records
- FDA 510(k) database K240501
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- Withdrawn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).
- CLEARCORRECT SYSTEM by Clearcorrect, Inc.
- 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) by 3M Company, Unitek Orthodontic Products
- Orthocaps Twinaligner by Ortho Caps GmbH
- AsoAligner by Aso International Manila, Inc.
- Argen Clear Aligner, Argen Clear Aligner Premium by The Argen Corporation
- Eon Aligner by Eon Dental Jordan, LLC
- Ormco Spark Aligner System by Sybron Dental Specialties, Inc.
- Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX by BLUE SKY BIO LLC
- Precision Align by Precision Align LLC
- U-Aligner by Universal Orthodontic Laboratory, Inc.