The following data is part of a premarket notification filed by Septodont with the FDA for Endosolv.
Device ID | K172839 |
510k Number | K172839 |
Device Name: | ENDOSOLV |
Classification | Resin, Root Canal Filling |
Applicant | Septodont 416 South Taylor Avenue Louisville, CO 80027 |
Contact | Jaimie Woodruff |
Correspondent | Jaimie Woodruff Septodont 416 South Taylor Avenue Louisville, CO 80027 |
Product Code | KIF |
CFR Regulation Number | 872.3820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-19 |
Decision Date | 2018-02-13 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDOSOLV 73630889 1441755 Live/Registered |
SCHILLER, HENRI 1986-11-17 |
ENDOSOLV 73570178 not registered Dead/Abandoned |
MANTEL, ANNY 1985-11-25 |