The following data is part of a premarket notification filed by Union Branch with the FDA for Endodontic Root Canal Plugger Finger-.
| Device ID | K831748 |
| 510k Number | K831748 |
| Device Name: | ENDODONTIC ROOT CANAL PLUGGER FINGER- |
| Classification | Plugger, Root Canal, Endodontic |
| Applicant | UNION BRANCH 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EKR |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-23 |
| Decision Date | 1983-07-12 |