The following data is part of a premarket notification filed by North Pacific Dental, Inc. with the FDA for Endomet.
Device ID | K830117 |
510k Number | K830117 |
Device Name: | ENDOMET |
Classification | Cement, Dental |
Applicant | NORTH PACIFIC DENTAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-11 |
Decision Date | 1983-03-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDOMET 73832603 1612624 Live/Registered |
SEPTODONT, SOCIETE ANONYME 1989-10-20 |
ENDOMET 73620868 not registered Dead/Abandoned |
MANTEL, ANNY 1986-09-19 |
ENDOMET 73565999 not registered Dead/Abandoned |
SCHILLER, HENRI 1985-10-31 |