The following data is part of a premarket notification filed by National Patent Development Corp. with the FDA for Root Canal Filling Applicator Needles.
| Device ID | K801484 |
| 510k Number | K801484 |
| Device Name: | ROOT CANAL FILLING APPLICATOR NEEDLES |
| Classification | Syringe, Periodontic, Endodontic, Irrigating |
| Applicant | NATIONAL PATENT DEVELOPMENT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EIC |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-16 |
| Decision Date | 1980-07-21 |