The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Vitique System.
| Device ID | K023649 |
| 510k Number | K023649 |
| Device Name: | VITIQUE SYSTEM |
| Classification | Cement, Dental |
| Applicant | DMG USA, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau DMG USA, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-30 |
| Decision Date | 2003-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDMG2130821 | K023649 | 000 |
| EDMG2130501 | K023649 | 000 |
| EDMG2130491 | K023649 | 000 |
| EDMG2130481 | K023649 | 000 |
| EDMG2130451 | K023649 | 000 |
| EDMG2130441 | K023649 | 000 |
| EDMG2130431 | K023649 | 000 |
| EDMG2130421 | K023649 | 000 |
| EDMG2130411 | K023649 | 000 |
| EDMG2130401 | K023649 | 000 |
| EDMG2130391 | K023649 | 000 |
| EDMG2130511 | K023649 | 000 |
| EDMG2130521 | K023649 | 000 |
| EDMG2130801 | K023649 | 000 |
| EDMG2202841 | K023649 | 000 |
| EDMG2202831 | K023649 | 000 |
| EDMG2202821 | K023649 | 000 |
| EDMG2202811 | K023649 | 000 |
| EDMG2131181 | K023649 | 000 |
| EDMG2130811 | K023649 | 000 |
| EDMG2130551 | K023649 | 000 |
| EDMG2130541 | K023649 | 000 |
| EDMG2130531 | K023649 | 000 |
| EDMG2130381 | K023649 | 000 |