The following data is part of a premarket notification filed by Dmg Usa Inc. with the FDA for Ecosite Bulk Fill.
| Device ID | K171772 |
| 510k Number | K171772 |
| Device Name: | Ecosite Bulk Fill |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DMG USA Inc. 23 Frank Mossberg Drive Attleboro, MA 02703 |
| Contact | Gordon Craig |
| Correspondent | Pam Papineau Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue 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 | 2017-06-14 |
| Decision Date | 2018-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDMG2207571 | K171772 | 000 |
| EDMG2229020 | K171772 | 000 |
| EDMG2229001 | K171772 | 000 |
| EDMG2207501 | K171772 | 000 |
| EDMG2207511 | K171772 | 000 |
| EDMG2207521 | K171772 | 000 |
| EDMG2207531 | K171772 | 000 |
| EDMG2207541 | K171772 | 000 |
| EDMG2207551 | K171772 | 000 |
| EDMG2207561 | K171772 | 000 |
| EDMG2229010 | K171772 | 000 |