The following data is part of a premarket notification filed by Sonendo, Inc. with the FDA for Sonendo Filling Material 5c.
| Device ID | K211995 |
| 510k Number | K211995 |
| Device Name: | Sonendo Filling Material 5C |
| Classification | Resin, Root Canal Filling |
| Applicant | Sonendo, Inc. 26061 Merit Circle, Suite 102 Laguna Hills, CA 92653 |
| Contact | Steve Ziemba |
| Correspondent | Steve Ziemba 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 | 2021-06-28 |
| Decision Date | 2021-08-27 |