The following data is part of a premarket notification filed by Sonendo, Inc. with the FDA for Sonendo Omniclean Endotherpay System Console, Sonendo Omniclean Molar Procedure Kit.
| Device ID | K133752 |
| 510k Number | K133752 |
| Device Name: | SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT |
| Classification | Scaler, Ultrasonic |
| Applicant | SONENDO, INC. 26061 MERIT CIRCLE, SUITE 101 Laguna Hills, CA 92653 |
| Contact | Dan Miller |
| Correspondent | Dan Miller SONENDO, INC. 26061 MERIT CIRCLE, SUITE 101 Laguna Hills, CA 92653 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-09 |
| Decision Date | 2014-05-15 |
| Summary: | summary |