The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Flowable Composite/ Ecuflow/ Luxaflow.
| Device ID | K011211 |
| 510k Number | K011211 |
| Device Name: | FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-19 |
| Decision Date | 2001-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDMG2240051 | K011211 | 000 |
| EDMG2117531 | K011211 | 000 |
| EDMG2117541 | K011211 | 000 |
| EDMG2117551 | K011211 | 000 |
| EDMG2117561 | K011211 | 000 |
| EDMG2240001 | K011211 | 000 |
| EDMG2240011 | K011211 | 000 |
| EDMG2240021 | K011211 | 000 |
| EDMG2240031 | K011211 | 000 |
| EDMG2240041 | K011211 | 000 |
| EDMG2117511 | K011211 | 000 |