The following data is part of a premarket notification filed by Ormco Corporation with the FDA for Spark Clear Aligner System.
| Device ID | K203737 |
| 510k Number | K203737 |
| Device Name: | Spark Clear Aligner System |
| Classification | Aligner, Sequential |
| Applicant | Ormco Corporation 200 S Kraemer Blvd Brea, CA 92821 |
| Contact | Frank Ray |
| Correspondent | Frank Ray Ormco Corporation 200 S Kraemer Blvd Brea, CA 92821 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-22 |
| Decision Date | 2021-03-22 |
| Summary: | summary |