The following data is part of a premarket notification filed by Techdent, Inc. with the FDA for Mcspadden Condensor.
| Device ID | K791019 |
| 510k Number | K791019 |
| Device Name: | MCSPADDEN CONDENSOR |
| Classification | Plugger, Root Canal, Endodontic |
| Applicant | TECHDENT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EKR |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-01 |
| Decision Date | 1979-08-03 |