The following data is part of a premarket notification filed by Pac-dent International, Inc. with the FDA for Pacendo Edta.
| Device ID | K153528 |
| 510k Number | K153528 |
| Device Name: | PacEndo EDTA |
| Classification | Cleanser, Root Canal |
| Applicant | PAC-DENT INTERNATIONAL, INC. 670 ENDEAVOR CIRCLE Brea, CA 92821 |
| Contact | Wenying Zhu |
| Correspondent | Wenying Zhu PAC-DENT INTERNATIONAL, INC. 670 ENDEAVOR CIRCLE Brea, CA 92821 |
| Product Code | KJJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-09 |
| Decision Date | 2016-02-01 |
| Summary: | summary |