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 |