The following data is part of a premarket notification filed by Cavitron Corp. with the FDA for Pinidentoflex Dental Polisher.
| Device ID | K780377 |
| 510k Number | K780377 |
| Device Name: | PINIDENTOFLEX DENTAL POLISHER |
| Classification | Point, Abrasive |
| Applicant | CAVITRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EHL |
| CFR Regulation Number | 872.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-08 |
| Decision Date | 1978-03-14 |