The following data is part of a premarket notification filed by Eurodent, Inc. with the FDA for Studio Uno.
| Device ID | K894061 |
| 510k Number | K894061 |
| Device Name: | STUDIO UNO |
| 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 | 1989-11-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STUDIO UNO 74636752 2116584 Dead/Cancelled |
Venture Stores, Inc. 1995-02-21 |
![]() STUDIO UNO 74286433 1821995 Dead/Cancelled |
Venture Stores, Inc. 1992-06-19 |
![]() STUDIO UNO 74143919 1825798 Dead/Cancelled |
Venture Stores, Inc. 1991-03-04 |