The following data is part of a premarket notification filed by Sonendo, Inc. with the FDA for Sonendo Material A.
| Device ID | K181922 |
| 510k Number | K181922 |
| Device Name: | Sonendo Material A |
| Classification | Resin, Root Canal Filling |
| Applicant | Sonendo, Inc. 26061 Merit Circle, Suite 102 Laguna Hills, CA 92653 |
| Contact | Eric Simon |
| Correspondent | Eric Simon Sonendo, Inc. 26061 Merit Circle, Suite 102 Laguna Hills, CA 92653 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-18 |
| Decision Date | 2018-10-22 |
| Summary: | summary |