The following data is part of a premarket notification filed by United Dental Mfg., Inc. with the FDA for Absorbent Endodontic Point.
| Device ID | K843017 |
| 510k Number | K843017 |
| Device Name: | ABSORBENT ENDODONTIC POINT |
| Classification | Point, Paper, Endodontic |
| Applicant | UNITED DENTAL MFG., INC. 2823 NORTH AUSTRALIAN AVE. West Palm Beach, FL 33407 |
| Contact | Edward Zdarsky |
| Correspondent | Edward Zdarsky UNITED DENTAL MFG., INC. 2823 NORTH AUSTRALIAN AVE. West Palm Beach, FL 33407 |
| Product Code | EKN |
| CFR Regulation Number | 872.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-31 |
| Decision Date | 1985-01-09 |