The following data is part of a premarket notification filed by United Dental Mfg., Inc. with the FDA for Endodontic Paper Points.
| Device ID | K812886 |
| 510k Number | K812886 |
| Device Name: | ENDODONTIC PAPER POINTS |
| Classification | Point, Paper, Endodontic |
| Applicant | UNITED DENTAL MFG., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EKN |
| CFR Regulation Number | 872.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-14 |
| Decision Date | 1981-11-16 |