The following data is part of a premarket notification filed by North Pacific Dental, Inc. with the FDA for Gutta Percha Points.
| Device ID | K830114 |
| 510k Number | K830114 |
| Device Name: | GUTTA PERCHA POINTS |
| Classification | Gutta-percha |
| Applicant | NORTH PACIFIC DENTAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EKM |
| CFR Regulation Number | 872.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-11 |
| Decision Date | 1983-03-01 |