Ormco Corporation · Class II · Cleared Feb 20, 2025
| K-number | K250487 |
| Device name | SparkTM Clear Aligner System |
| Applicant | Ormco Corporation |
| Product code | NXC |
| Device class | Class II |
| Decision date | Feb 20, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.5470 |
The Spark Clear Aligner System is a series of doctor-prescribed, custom-manufactured thin clear plastic removable orthodontic appliances that gradually move teeth to correct malocclusion. The aligners are provided sequentially in stages and held in place by pressure, with integrated occlusion guides to help address Class II malocclusions.
Not stated in this summary.
The device conforms to ANSI/AAMI ISO standards 10993-1:2018, 10993-5:2009/(R)2014, 10993-10:2010/(R)2014, and 10993-11:2017; ISO 7405 Third edition 2018; ASTM F1980-21; ANSI/ADA Standard No. 41-2020; and ANSI/AAMI ISO 14971:2019.
The Spark Clear Aligner System shares identical indications for use with its predicate devices (Clear Aligner, K223517, and Spark Clear Aligner System, K240501), both classified as sequential aligners with product code NXC under the same regulation (21 CFR 872.5470). The subject device uses the same technology platform and intended purpose as the predicates, differing only in incremental design refinements. Compliance with the same consensus standards and regulatory requirements as established predicates demonstrates substantial equivalence.
View the full FDA submission: accessdata.fda.gov