The following data is part of a premarket notification filed by North Pacific Dental, Inc. with the FDA for Hydrol.
Device ID | K830112 |
510k Number | K830112 |
Device Name: | HYDROL |
Classification | Liner, Cavity, Calcium Hydroxide |
Applicant | NORTH PACIFIC DENTAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EJK |
CFR Regulation Number | 872.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-11 |
Decision Date | 1983-02-18 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HYDROL 90154828 not registered Live/Pending |
Shield Middle East FZCO 2020-09-02 |
HYDROL 78365069 not registered Dead/Abandoned |
NVIROHEALTH, INC. 2004-02-09 |
HYDROL 74709480 not registered Dead/Abandoned |
Kayban Pty Ltd. 1995-08-01 |
HYDROL 73563860 not registered Dead/Abandoned |
SCHILLER, HENRI 1985-10-18 |
HYDROL 73282892 1214638 Dead/Cancelled |
Schiller; Henri Numa Marcel 1980-10-22 |
HYDROL 72402170 0949919 Dead/Cancelled |
SCM CORPORATION 1971-09-07 |
HYDROL 72205897 0798698 Dead/Expired |
WHITMOYER LABORATORIES, INC. 1964-11-09 |