The following data is part of a premarket notification filed by Endodent, Inc. with the FDA for Point, Paper Endodontic.
| Device ID | K830814 |
| 510k Number | K830814 |
| Device Name: | POINT, PAPER ENDODONTIC |
| Classification | Cleanser, Root Canal |
| Applicant | ENDODENT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KJJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-15 |
| Decision Date | 1983-04-06 |