The following data is part of a premarket notification filed by Smile Development Corp with the FDA for Angel Align System.
| Device ID | K171674 |
| 510k Number | K171674 |
| Device Name: | Angel Align System |
| Classification | Aligner, Sequential |
| Applicant | Smile Development Corp 7179 Cherrywood Ct Highland, CA 92346 |
| Contact | Ian Kitching |
| Correspondent | Ian Kitching Smile Development Corp 7179 Cherrywood Ct Highland, CA 92346 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-06 |
| Decision Date | 2018-01-19 |
| Summary: | summary |