The following data is part of a premarket notification filed by Sybron Dental Specialties with the FDA for Ormco Spark Aligner System.
| Device ID | K182826 |
| 510k Number | K182826 |
| Device Name: | Ormco Spark Aligner System |
| Classification | Aligner, Sequential |
| Applicant | Sybron Dental Specialties 1717 W. Collins Ave. Orange, CA 92687 |
| Contact | Mey Saied |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-10-05 |
| Decision Date | 2018-10-11 |
| Summary: | summary |