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 |