The following data is part of a premarket notification filed by Eurodent, Inc. with the FDA for Isodent.
| Device ID | K894058 |
| 510k Number | K894058 |
| Device Name: | ISODENT |
| Classification | Unit, Operative Dental |
| 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 | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-07 |
| Decision Date | 1989-12-21 |