The following data is part of a premarket notification filed by Denimed Electronica S.h. with the FDA for Mare Dental Operative Unit.
| Device ID | K041458 |
| 510k Number | K041458 |
| Device Name: | MARE DENTAL OPERATIVE UNIT |
| Classification | Unit, Operative Dental |
| Applicant | DENIMED ELECTRONICA S.H. 1460 NW 107 AVE. SUITE G Miami, FL 33172 |
| Contact | George Echeverri |
| Correspondent | George Echeverri DENIMED ELECTRONICA S.H. 1460 NW 107 AVE. SUITE G Miami, FL 33172 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-01 |
| Decision Date | 2004-08-24 |
| Summary: | summary |