The following data is part of a premarket notification filed by Eurodent, Inc. with the FDA for Esse Quattro/esse Uno.
| Device ID | K894060 |
| 510k Number | K894060 |
| Device Name: | ESSE QUATTRO/ESSE UNO |
| Classification | Chair, Dental, With Operative Unit |
| Applicant | EURODENT, INC. 1381, RUE AMPERE BOUCHERVILLE, QUEBEC Canada J4b 5z5, CA |
| Contact | Aldo Marucchi-foino |
| Correspondent | Aldo Marucchi-foino EURODENT, INC. 1381, RUE AMPERE BOUCHERVILLE, QUEBEC Canada J4b 5z5, CA |
| Product Code | KLC |
| CFR Regulation Number | 872.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-07 |
| Decision Date | 1989-09-07 |