The following data is part of a premarket notification filed by Genesis Industries, Inc. with the FDA for Rx Nysp Pentron 60.
| Device ID | K833282 |
| 510k Number | K833282 |
| Device Name: | RX NYSP PENTRON 60 |
| Classification | Remover, Crown |
| Applicant | GENESIS INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EIS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-22 |
| Decision Date | 1983-11-28 |