The following data is part of a premarket notification filed by Endodent, Inc. with the FDA for Gutta Percha Points.
| Device ID | K863638 |
| 510k Number | K863638 |
| Device Name: | GUTTA PERCHA POINTS |
| Classification | Gutta-percha |
| Applicant | ENDODENT, INC. 135 E. CHESTNUT AVE. SUITE 5, P.O. BOX 1606 Monrovia, CA 91016 |
| Contact | Max Lenz |
| Correspondent | Max Lenz ENDODENT, INC. 135 E. CHESTNUT AVE. SUITE 5, P.O. BOX 1606 Monrovia, CA 91016 |
| Product Code | EKM |
| CFR Regulation Number | 872.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-17 |
| Decision Date | 1986-10-30 |