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 |