The following data is part of a premarket notification filed by Straight Smile, Llc with the FDA for Byte Aligner System.
| Device ID | K180346 |
| 510k Number | K180346 |
| Device Name: | Byte Aligner System |
| Classification | Aligner, Sequential |
| Applicant | Straight Smile, LLC 528 Palisades Drive, #553 Pacific Palisades, CA 90272 |
| Contact | Sepi Abbasi |
| Correspondent | Craig Coombs Coombs Medical Device Consulting, Inc. 1193 Sherman St Alameda, CA 94501 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-08 |
| Decision Date | 2019-02-19 |
| Summary: | summary |