The following data is part of a premarket notification filed by Great Lakes Orthodontics Ltd with the FDA for Smart Moves Complete.
| Device ID | K172765 |
| 510k Number | K172765 |
| Device Name: | Smart Moves Complete |
| Classification | Aligner, Sequential |
| Applicant | Great Lakes Orthodontics Ltd 200 Cooper Ave Tonawanda, NY 14150 |
| Contact | David Graver |
| Correspondent | David Graver Great Lakes Orthodontics Ltd 200 Cooper Ave Tonawanda, NY 14150 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-13 |
| Decision Date | 2018-06-01 |
| Summary: | summary |