The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Primaflow.
| Device ID | K002086 |
| 510k Number | K002086 |
| Device Name: | PRIMAFLOW |
| Classification | Material, Tooth Shade, Resin |
| 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-10 |
| Decision Date | 2000-08-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PRIMAFLOW 77116217 not registered Dead/Abandoned |
Fleetpride, Inc. 2007-02-26 |
![]() PRIMAFLOW 76176187 not registered Dead/Abandoned |
Ernst Muhlbauer KG 2000-12-05 |
![]() PRIMAFLOW 74131784 not registered Dead/Abandoned |
ALBANY INTERNATIONAL CORP. 1991-01-22 |